Trial Outcomes & Findings for A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients (NCT NCT03821272)
NCT ID: NCT03821272
Last Updated: 2025-10-08
Results Overview
To evaluate the safety of a 7-injection regimen of PepCan, adverse events will be captured and assessed per NCI CTCAE Version 5.0 whether they are treatment-related or not by a physician.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
2 years
Results posted on
2025-10-08
Participant Flow
Participant milestones
| Measure |
PepCan
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
|
Placebo
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Placebo: 0.9% Saline solution per dose administered intradermally in the extremities
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
5
|
|
Overall Study
COMPLETED
|
9
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
PepCan
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
|
Placebo
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Placebo: 0.9% Saline solution per dose administered intradermally in the extremities
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients
Baseline characteristics by cohort
| Measure |
PepCan
n=12 Participants
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
|
Placebo
n=5 Participants
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Placebo: 0.9% Saline solution per dose administered intradermally in the extremities
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.03 years
STANDARD_DEVIATION 8.30 • n=99 Participants
|
59.34 years
STANDARD_DEVIATION 14.00 • n=107 Participants
|
59.82 years
STANDARD_DEVIATION 9.82 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
5 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
White blood cells
|
5.20 10^3 cells/μL
STANDARD_DEVIATION 1.52 • n=99 Participants
|
4.64 10^3 cells/μL
STANDARD_DEVIATION 1.70 • n=107 Participants
|
5.03 10^3 cells/μL
STANDARD_DEVIATION 1.55 • n=206 Participants
|
|
Hemoglobin
|
11.94 g/dL
STANDARD_DEVIATION 1.91 • n=99 Participants
|
10.88 g/dL
STANDARD_DEVIATION 1.43 • n=107 Participants
|
11.63 g/dL
STANDARD_DEVIATION 1.81 • n=206 Participants
|
|
Hematocrit
|
36.63 %
STANDARD_DEVIATION 5.73 • n=99 Participants
|
32.96 %
STANDARD_DEVIATION 4.64 • n=107 Participants
|
35.55 %
STANDARD_DEVIATION 5.56 • n=206 Participants
|
|
Body mass index
|
22.30 kg/m2
STANDARD_DEVIATION 3.82 • n=99 Participants
|
21.86 kg/m2
STANDARD_DEVIATION 4.41 • n=107 Participants
|
22.17 kg/m2
STANDARD_DEVIATION 3.87 • n=206 Participants
|
|
Human papillomavirus status
Positive
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Human papillomavirus status
Negative
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Human papillomavirus status
Unknown
|
12 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
P16
P16 positive
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
P16
P16 negative
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
P16
P16 unknown
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Human Papillomavirus/P16
HPV/P16 positive
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Human Papillomavirus/P16
HPV/P16 negative
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Human Papillomavirus/P16
HPV/P16 unknown
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Tumor location
Site: Pharynx
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Tumor location
Site: Larynx
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Tumor location
Site: Oral
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
TNM Staging, Tumor
TNM Staging, Tumor: T1
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
TNM Staging, Tumor
TNM Staging, Tumor: T2
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
TNM Staging, Tumor
TNM Staging, Tumor: T3
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
TNM Staging, Tumor
TNM Staging, Tumor: T4
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
TNM Staging, Lymph node
TNM Staging, Lymph node: N0
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
TNM Staging, Lymph node
TNM Staging, Lymph node: N1
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
TNM Staging, Lymph node
TNM Staging, Lymph node: N2
|
8 participants
n=99 Participants
|
2 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
TNM Staging, Lymph node
TNM Staging, Lymph node: N3
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
TNM Staging, Metastasis: M0
MX
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
TNM Staging, Metastasis: M0
M0
|
12 participants
n=99 Participants
|
5 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
TNM Staging, Metastasis: M0
M1
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants with side effects occurring with 5% or more injections.
To evaluate the safety of a 7-injection regimen of PepCan, adverse events will be captured and assessed per NCI CTCAE Version 5.0 whether they are treatment-related or not by a physician.
Outcome measures
| Measure |
PepCan
n=12 Participants
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
|
Placebo
n=5 Participants
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Placebo: 0.9% Saline solution per dose administered intradermally in the extremities
|
|---|---|---|
|
Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan.
Nervous System Disorders : Dizziness
|
1 adverse event
|
0 adverse event
|
|
Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan.
Nervous System Disorders : Headache
|
2 adverse event
|
0 adverse event
|
|
Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan.
Skin and Subcutaneous Tissue Disorders : Pruritus
|
1 adverse event
|
0 adverse event
|
|
Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan.
General Disorders and Site Administration Conditions: Injection site reaction
|
23 adverse event
|
0 adverse event
|
|
Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan.
General Disorders and Site Administration Conditions: Fatigue
|
0 adverse event
|
1 adverse event
|
|
Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan.
Immune System Disorders : Allergic reaction
|
2 adverse event
|
0 adverse event
|
|
Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan.
Injury, Poisoning and Procedural Complications : Vaccination complication
|
4 adverse event
|
1 adverse event
|
|
Adverse Events - Evaluate Safety of a 7-injection Regimen of PepCan.
Metabolism and Nutrition Disorders: Hypokalemia
|
1 adverse event
|
0 adverse event
|
SECONDARY outcome
Timeframe: Study completion, approximately 24 months after enrollmentPopulation: Patients who screen-failed or were considered ineligible were excluded from the ITT analysis and PP analysis..
To evaluate the efficacy, cancer recurrence rates will be compared between the PepCan and placebo arms. Patients with a "non-recurrence" status are defined as responders. Patients with a "recurrence" status are defined as non-responders.
Outcome measures
| Measure |
PepCan
n=12 Participants
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
|
Placebo
n=5 Participants
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Placebo: 0.9% Saline solution per dose administered intradermally in the extremities
|
|---|---|---|
|
Cancer Recurrence Rate - Efficacy of a 7-injection Regimen of PepCan
Non-recurrence
|
5 Participants
|
4 Participants
|
|
Cancer Recurrence Rate - Efficacy of a 7-injection Regimen of PepCan
Withdrawn
|
2 Participants
|
0 Participants
|
|
Cancer Recurrence Rate - Efficacy of a 7-injection Regimen of PepCan
Ineligible
|
1 Participants
|
0 Participants
|
|
Cancer Recurrence Rate - Efficacy of a 7-injection Regimen of PepCan
Recurrence
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Study completion, approximately 24 months after enrollmentPopulation: Patients who screen-failed or were considered ineligible were excluded from the ITT analysis.
Patients with a "non-recurrence" status are defined as responders. Patients with a "recurrence" status are defined as non-responders. The Intention-to-Treat outcome is based on the worst-case scenario and considers those who withdrew as non-responders. Patients who screen-failed or were considered ineligible were excluded from the ITT analysis.
Outcome measures
| Measure |
PepCan
n=12 Participants
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
|
Placebo
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Placebo: 0.9% Saline solution per dose administered intradermally in the extremities
|
|---|---|---|
|
Efficacy Analysis (Intention to Treat) - PepCan
Non-responder
|
6 Participants
|
—
|
|
Efficacy Analysis (Intention to Treat) - PepCan
Unknown
|
1 Participants
|
—
|
|
Efficacy Analysis (Intention to Treat) - PepCan
Responder
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Study completion, approximately 24 months after enrollmentPopulation: Patients who screen-failed or were considered ineligible were excluded from the ITT analysis.
Patients with a "non-recurrence" status are defined as responders. Patients with a "recurrence" status are defined as non-responders. The Intention-to-Treat outcome is based on the worst-case scenario and considers those who withdrew as non-responders. Patients who screen-failed or were considered ineligible were excluded from the ITT analysis.
Outcome measures
| Measure |
PepCan
n=5 Participants
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
|
Placebo
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Placebo: 0.9% Saline solution per dose administered intradermally in the extremities
|
|---|---|---|
|
Efficacy Analysis (Intention to Treat) - Placebo
Non-responder
|
1 Participants
|
—
|
|
Efficacy Analysis (Intention to Treat) - Placebo
Unknown
|
0 Participants
|
—
|
|
Efficacy Analysis (Intention to Treat) - Placebo
Responder
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Study completion, approximately 24 months after enrollmentPopulation: Patients who screen-failed, withdrew, or were considered ineligible (after randomization) are excluded from the PP analysis.
The Per Protocol outcome includes subjects who completed the study either by completing Visit 9 or having had recurrences. Patients who screen-failed, withdrew, or were considered ineligible (after randomization) are excluded from the PP analysis.
Outcome measures
| Measure |
PepCan
n=12 Participants
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
|
Placebo
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Placebo: 0.9% Saline solution per dose administered intradermally in the extremities
|
|---|---|---|
|
Efficacy Analysis (Per Protocol) - PepCan
Responder
|
5 Participants
|
—
|
|
Efficacy Analysis (Per Protocol) - PepCan
Non-responder
|
4 Participants
|
—
|
|
Efficacy Analysis (Per Protocol) - PepCan
Unknown
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Study completion, approximately 24 months after enrollmentPopulation: Patients who screen-failed, withdrew, or were considered ineligible (after randomization) are excluded from the PP analysis.
The Per Protocol outcome includes subjects who completed the study either by completing Visit 9 or having had recurrences. Patients who screen-failed, withdrew, or were considered ineligible (after randomization) are excluded from the PP analysis.
Outcome measures
| Measure |
PepCan
n=5 Participants
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
|
Placebo
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Placebo: 0.9% Saline solution per dose administered intradermally in the extremities
|
|---|---|---|
|
Efficacy Analysis (Per Protocol) - Placebo
Unknown
|
0 Participants
|
—
|
|
Efficacy Analysis (Per Protocol) - Placebo
Responder
|
4 Participants
|
—
|
|
Efficacy Analysis (Per Protocol) - Placebo
Non-responder
|
1 Participants
|
—
|
Adverse Events
PepCan
Serious events: 5 serious events
Other events: 12 other events
Deaths: 1 deaths
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PepCan
n=12 participants at risk
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
|
Placebo
n=5 participants at risk
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Placebo: 0.9% Saline solution per dose administered intradermally in the extremities
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
8.3%
1/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
General disorders
Gait disturbance
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Infections and infestations
Bacteremia
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
Weight loss
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
8.3%
1/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
16.7%
2/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
Other adverse events
| Measure |
PepCan
n=12 participants at risk
Four injections (one every 3 weeks) of PepCan, then three injections (one every 3 months) of PepCan for a total of 7 injections.
PepCan: 50 μg peptide + 0.3mL Candin® per dose administered intradermally in the extremities
|
Placebo
n=5 participants at risk
Four injections (one every 3 weeks) of placebo, then three injections (one every 3 months) of placebo for a total of 7 injections.
Placebo: 0.9% Saline solution per dose administered intradermally in the extremities
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
6/12 • Number of events 7 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Immune system disorders
Allergic reaction
|
25.0%
3/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Blood and lymphatic system disorders
Anemia
|
83.3%
10/12 • Number of events 18 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
100.0%
5/5 • Number of events 12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Anorexia
|
41.7%
5/12 • Number of events 6 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
40.0%
2/5 • Number of events 4 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Psychiatric disorders
Anxiety
|
25.0%
3/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
2/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
3/12 • Number of events 4 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
40.0%
2/5 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
Blood antidiuretic hormone abnormal
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
Blood bilirubin increased
|
16.7%
2/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Eye disorders
Blurred vision
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Cardiac disorders
Chest pain - cardiac
|
16.7%
2/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
General disorders
Chills
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
Cholesterol high
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Number of events 4 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
60.0%
3/5 • Number of events 4 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
2/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
40.0%
2/5 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
Creatinine increased
|
25.0%
3/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
40.0%
2/5 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Psychiatric disorders
Depression
|
33.3%
4/12 • Number of events 4 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
40.0%
2/5 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
2/12 • Number of events 4 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Nervous system disorders
Dizziness
|
25.0%
3/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Eye disorders
Dry eye
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Dry mouth
|
83.3%
10/12 • Number of events 17 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
100.0%
5/5 • Number of events 7 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Nervous system disorders
Dysgeusia
|
58.3%
7/12 • Number of events 10 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
60.0%
3/5 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Dysphagia
|
75.0%
9/12 • Number of events 15 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
80.0%
4/5 • Number of events 9 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Nervous system disorders
Dysphasia
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
2/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Ear and labyrinth disorders
Ear pain
|
25.0%
3/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
General disorders
Edema face
|
16.7%
2/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Esophageal stenosis
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
40.0%
2/5 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
General disorders
Facial pain
|
8.3%
1/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
General disorders
Fatigue
|
66.7%
8/12 • Number of events 8 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
80.0%
4/5 • Number of events 5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
General disorders
Gait disturbance
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
33.3%
4/12 • Number of events 8 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
40.0%
2/5 • Number of events 7 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Gastroparesis
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Nervous system disorders
Headache
|
33.3%
4/12 • Number of events 5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
40.0%
2/5 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Ear and labyrinth disorders
Hearing impaired
|
41.7%
5/12 • Number of events 5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Cardiac disorders
Heart failure
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Vascular disorders
Hematoma
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
25.0%
3/12 • Number of events 4 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
8/12 • Number of events 9 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
40.0%
2/5 • Number of events 4 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Vascular disorders
Hypertension
|
58.3%
7/12 • Number of events 8 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
60.0%
3/5 • Number of events 5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Endocrine disorders
Hyperthyroidism
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
4/12 • Number of events 5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
100.0%
5/5 • Number of events 8 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
3/12 • Number of events 14 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
2/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
6/12 • Number of events 10 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
100.0%
5/5 • Number of events 10 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Endocrine disorders
Hypothyroidism
|
41.7%
5/12 • Number of events 8 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
60.0%
3/5 • Number of events 5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Infections and infestations
Infections and infestations - Other, specify
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
General disorders
Injection site reaction
|
83.3%
10/12 • Number of events 23 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
Investigations - Other, specify
|
75.0%
9/12 • Number of events 33 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
60.0%
3/5 • Number of events 13 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Vascular disorders
Lymphedema
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
Lymphocyte count decreased
|
91.7%
11/12 • Number of events 34 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
100.0%
5/5 • Number of events 19 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
General disorders
Malaise
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Nervous system disorders
Memory impairment
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
25.0%
3/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
40.0%
2/5 • Number of events 5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
Neutrophil count decreased
|
8.3%
1/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Oral pain
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
40.0%
2/5 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
General disorders
Pain
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
2/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Pancreatitis
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Nervous system disorders
Paresthesia
|
16.7%
2/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
Platelet count decreased
|
16.7%
2/12 • Number of events 4 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Renal and urinary disorders
Proteinuria
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
8.3%
1/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
16.7%
2/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Infections and infestations
Shingles
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
16.7%
2/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Infections and infestations
Skin infection
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
4/12 • Number of events 5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
60.0%
3/5 • Number of events 5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Nervous system disorders
Spasticity
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
16.7%
2/12 • Number of events 4 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Infections and infestations
Thrush
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Ear and labyrinth disorders
Tinnitus
|
33.3%
4/12 • Number of events 5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
60.0%
3/5 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
8.3%
1/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Infections and infestations
Upper respiratory infection
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
16.7%
2/12 • Number of events 4 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Vascular disorders
Vascular disorders - Other, specify
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
Weight loss
|
41.7%
5/12 • Number of events 9 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Investigations
White blood cell decreased
|
33.3%
4/12 • Number of events 10 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
60.0%
3/5 • Number of events 10 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
General disorders
Neck edema
|
25.0%
3/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Infections and infestations
Bone infection
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
16.7%
2/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Eye disorders
Scleral disorder
|
8.3%
1/12 • Number of events 2 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
8.3%
1/12 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Renal and urinary disorders
Chronic kidney disease
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
8.3%
1/12 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
0.00%
0/5 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
4/12 • Number of events 4 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
40.0%
2/5 • Number of events 3 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/12 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
20.0%
1/5 • Number of events 1 • Approximately 24 months
Not based on a different definition of adverse event and/or serious adverse event than the Adverse Events definition on clinicaltrials.gov
|
Additional Information
Mayumi Nakagawa, M.D., Ph.D.
University of Arkansas for Medical Sciences
Phone: (501) 686-8635
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place