Trial Outcomes & Findings for Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma (NCT NCT03200847)
NCT ID: NCT03200847
Last Updated: 2024-10-01
Results Overview
MTD is defined as the highest dose level with no more than 3 DLTs reported in 6 DLT-evaluable subjects. A target toxicity rate of approximately 33% of all 24 patients will be used to establish the RP2D. This is one part of the pembrolizumab-ATRA combination treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
21 days from first dose of combined treatment
Results posted on
2024-10-01
Participant Flow
No de-escalation occurred. All subjects received 150 mg/m2 for 3 days before and after each of the first four infusions of pembrolizumab.
Participant milestones
| Measure |
Pembrolizumab With All-Trans Retinoic Acid
Patients will receive pembrolizumab infusions every three weeks. Patients will also receive 3 days of all-trans retinoic acid treatment surrounding each of the first 4 infusions of pembrolizumab, beginning one day prior to the infusion (a total of 12 days of all-trans retinoic acid).
Pembrolizumab with All-Trans Retinoic Acid: All the patients will receive 200mg Q3W pembrolizumab treatment plus the supplemental treatment of 150 mg/m2 All-Trans Retinoic Acid orally for 3 days surrounding each of the first four infusions of pembrolizumab
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
Baseline characteristics by cohort
| Measure |
Pembrolizumab With All-Trans Retinoic Acid
n=25 Participants
Patients will receive pembrolizumab infusions every three weeks. Patients will also receive 3 days of all-trans retinoic acid treatment surrounding each of the first 4 infusions of pembrolizumab, beginning one day prior to the infusion (a total of 12 days of all-trans retinoic acid).
Pembrolizumab with All-Trans Retinoic Acid: All the patients will receive 200mg Q3W pembrolizumab treatment plus the supplemental treatment of 150 mg/m2 All-Trans Retinoic Acid orally for 3 days surrounding each of the first four infusions of pembrolizumab
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 13.38843 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 21 days from first dose of combined treatmentPopulation: The analysis population is 24 patients rather than 25 because one patient was not on treatment long enough to be evaluated for any outcomes.
MTD is defined as the highest dose level with no more than 3 DLTs reported in 6 DLT-evaluable subjects. A target toxicity rate of approximately 33% of all 24 patients will be used to establish the RP2D. This is one part of the pembrolizumab-ATRA combination treatment.
Outcome measures
| Measure |
Pembrolizumab With All-Trans Retinoic Acid
n=24 Participants
Patients will receive pembrolizumab infusions every three weeks. Patients will also receive 3 days of all-trans retinoic acid treatment surrounding each of the first 4 infusions of pembrolizumab, beginning one day prior to the infusion (a total of 12 days of all-trans retinoic acid).
Pembrolizumab with All-Trans Retinoic Acid: All the patients will receive 200mg Q3W pembrolizumab treatment plus the supplemental treatment of 150 mg/m2 All-Trans Retinoic Acid orally for 3 days surrounding each of the first four infusions of pembrolizumab
|
|---|---|
|
Maximally Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Pembrolizumab
|
200 mg
|
PRIMARY outcome
Timeframe: 21 days from first dose of combined treatmentPopulation: The analysis population is 24 patients rather than 25 because one patient was not on treatment long enough to be evaluated for any outcomes.
MTD is defined as the highest dose level with no more than 3 DLT reported in 6 DLT-evaluable subjects. A target toxicity rate of approximately 33% of all 24 patients will be used to establish the RP2D. This dose is one part of the pembrolizumab-ATRA combination treatment.
Outcome measures
| Measure |
Pembrolizumab With All-Trans Retinoic Acid
n=24 Participants
Patients will receive pembrolizumab infusions every three weeks. Patients will also receive 3 days of all-trans retinoic acid treatment surrounding each of the first 4 infusions of pembrolizumab, beginning one day prior to the infusion (a total of 12 days of all-trans retinoic acid).
Pembrolizumab with All-Trans Retinoic Acid: All the patients will receive 200mg Q3W pembrolizumab treatment plus the supplemental treatment of 150 mg/m2 All-Trans Retinoic Acid orally for 3 days surrounding each of the first four infusions of pembrolizumab
|
|---|---|
|
Maximally Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of All-Trans Retinoic Acid
|
150 mg/m2
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The analysis population is 24 patients rather than 25 because one patient was not on treatment long enough to be evaluated for any outcomes.
Toxicity is evaluated according to NCI CTCAE Version 4.0. A dose limiting toxicity (DLT) is defined as any grade 3 or higher adverse event related to VESNOID (the all-trans retinoic acid) and/or pembrolizumab.
Outcome measures
| Measure |
Pembrolizumab With All-Trans Retinoic Acid
n=24 Participants
Patients will receive pembrolizumab infusions every three weeks. Patients will also receive 3 days of all-trans retinoic acid treatment surrounding each of the first 4 infusions of pembrolizumab, beginning one day prior to the infusion (a total of 12 days of all-trans retinoic acid).
Pembrolizumab with All-Trans Retinoic Acid: All the patients will receive 200mg Q3W pembrolizumab treatment plus the supplemental treatment of 150 mg/m2 All-Trans Retinoic Acid orally for 3 days surrounding each of the first four infusions of pembrolizumab
|
|---|---|
|
Number of Patients With a Dose-Limiting Toxicity (DLT) for the Combined Treatment of Pembrolizumab and All-Trans Retinoic Acid
|
5 Participants
|
SECONDARY outcome
Timeframe: up to 36 monthsPopulation: The analysis population is 24 patients rather than 25 because one patient was not on treatment long enough to be evaluated for any outcomes.
Progression free survival was calculated from treatment start date to data cutoff date.
Outcome measures
| Measure |
Pembrolizumab With All-Trans Retinoic Acid
n=24 Participants
Patients will receive pembrolizumab infusions every three weeks. Patients will also receive 3 days of all-trans retinoic acid treatment surrounding each of the first 4 infusions of pembrolizumab, beginning one day prior to the infusion (a total of 12 days of all-trans retinoic acid).
Pembrolizumab with All-Trans Retinoic Acid: All the patients will receive 200mg Q3W pembrolizumab treatment plus the supplemental treatment of 150 mg/m2 All-Trans Retinoic Acid orally for 3 days surrounding each of the first four infusions of pembrolizumab
|
|---|---|
|
Progression Free Survival
|
20.3 months
Interval 7.6 to
The upper limit of the calculated 95% confidence interval was not estimable because there were not enough patients who had events at later timepoints to get a reliable upper estimate.
|
SECONDARY outcome
Timeframe: Pre-treatment (0-30 days before first ATRA administration) and post-treatment (84-130 days after first ATRA administration)Population: Percent change in MDSC was computed both in total and separately for i) patients that responded to therapy, and ii) patients that did not respond to therapy. Response was evaluated using RECIST v1.1 criteria. The analysis population for this outcome measure is 23 patients because one patient did not complete a post-treatment blood draw.
Anti-tumor activity will be determined by the percent change in MDSC (immunosuppressive myeloid-derived suppressor cells) frequency in peripheral blood of advanced melanoma patients undergoing the combined treatment of pembrolizumab and All-Trans Retinoic Acid (ATRA). Pre-treatment levels will be compared to post-treatment levels, where post-treatment means 4-6 weeks after stopping ATRA. MDSCs include CD45+, CD3-, CD19-, CD56-, CD11b+, CD33+, and HLA-DR-/low. In the original protocol, suppressive function was included as part of this outcome measure to assess anti-tumor activity. However, this analysis could not be performed because the decrease in concentration of MDSCs after treatment resulted in inadequate data for the planned assays.
Outcome measures
| Measure |
Pembrolizumab With All-Trans Retinoic Acid
n=23 Participants
Patients will receive pembrolizumab infusions every three weeks. Patients will also receive 3 days of all-trans retinoic acid treatment surrounding each of the first 4 infusions of pembrolizumab, beginning one day prior to the infusion (a total of 12 days of all-trans retinoic acid).
Pembrolizumab with All-Trans Retinoic Acid: All the patients will receive 200mg Q3W pembrolizumab treatment plus the supplemental treatment of 150 mg/m2 All-Trans Retinoic Acid orally for 3 days surrounding each of the first four infusions of pembrolizumab
|
|---|---|
|
Percent Change in Anti-Tumor Activity
Responding patients
|
-48.6 percent change from pre-treatment value
Standard Deviation 54.4
|
|
Percent Change in Anti-Tumor Activity
Non-responding patients
|
109.7 percent change from pre-treatment value
Standard Deviation 224.6
|
|
Percent Change in Anti-Tumor Activity
Overall
|
-7.3 percent change from pre-treatment value
Standard Deviation 136.6
|
Adverse Events
Pembrolizumab With All-Trans Retinoic Acid
Serious events: 12 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pembrolizumab With All-Trans Retinoic Acid
n=25 participants at risk
Patients will receive pembrolizumab infusions every three weeks. Patients will also receive 3 days of all-trans retinoic acid treatment surrounding each of the first 4 infusions of pembrolizumab, beginning one day prior to the infusion (a total of 12 days of all-trans retinoic acid).
Pembrolizumab with All-Trans Retinoic Acid: All the patients will receive 200mg Q3W pembrolizumab treatment plus the supplemental treatment of 150 mg/m2 All-Trans Retinoic Acid orally for 3 days surrounding each of the first four infusions of pembrolizumab
|
|---|---|
|
Renal and urinary disorders
Adrenal insufficiency
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
DVT
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Confusion
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Encephalopathy
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Fatigue
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
4.0%
1/25 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Malaise
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Infections and infestations
Meningitis
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Shoulder Dislocation
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Prostate Adenocarcinoma
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Nervous system disorders
Cerebrovascular Event
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Hypoxic Respiratory Failure
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Nervous system disorders
Seizure
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Stroke
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
Intramedullary nail fixation of L humerus surgery
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Thrombolytic Event
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Acute kidney insufficiency
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Altered mental status due to new brain mets
|
4.0%
1/25 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Pembrolizumab With All-Trans Retinoic Acid
n=25 participants at risk
Patients will receive pembrolizumab infusions every three weeks. Patients will also receive 3 days of all-trans retinoic acid treatment surrounding each of the first 4 infusions of pembrolizumab, beginning one day prior to the infusion (a total of 12 days of all-trans retinoic acid).
Pembrolizumab with All-Trans Retinoic Acid: All the patients will receive 200mg Q3W pembrolizumab treatment plus the supplemental treatment of 150 mg/m2 All-Trans Retinoic Acid orally for 3 days surrounding each of the first four infusions of pembrolizumab
|
|---|---|
|
General disorders
Abdominal Pain
|
12.0%
3/25 • Number of events 3 • 2 years
|
|
Endocrine disorders
Adrenal Insufficiency
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Alanine aminotransferase increased
|
24.0%
6/25 • Number of events 8 • 2 years
|
|
Blood and lymphatic system disorders
Alkaline Phosphatase Increase
|
8.0%
2/25 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
12.0%
3/25 • Number of events 3 • 2 years
|
|
General disorders
Alopecia
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
24.0%
6/25 • Number of events 8 • 2 years
|
|
General disorders
anorexia
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
Psychiatric disorders
anxiety
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Arthralgia
|
8.0%
2/25 • Number of events 3 • 2 years
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
20.0%
5/25 • Number of events 5 • 2 years
|
|
General disorders
Back Pain
|
12.0%
3/25 • Number of events 3 • 2 years
|
|
Infections and infestations
Bladder Infection
|
4.0%
1/25 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Hypothyroid
|
12.0%
3/25 • Number of events 3 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Endocrine disorders
Elevated TSH
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Chronic anticoagulation
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Eye disorders
Blurred Vision
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Bruising
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Cardiac disorders
Hypertension
|
8.0%
2/25 • Number of events 3 • 2 years
|
|
Cardiac disorders
R Bundle Branch Block w/L Anterior Fascia Block
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Chills
|
4.0%
1/25 • Number of events 2 • 2 years
|
|
Psychiatric disorders
Confusion
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
16.0%
4/25 • Number of events 5 • 2 years
|
|
General disorders
Cough
|
24.0%
6/25 • Number of events 7 • 2 years
|
|
Renal and urinary disorders
Creatinine Increased
|
16.0%
4/25 • Number of events 4 • 2 years
|
|
General disorders
Dehydration
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
General disorders
Dental Caries
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
5/25 • Number of events 9 • 2 years
|
|
General disorders
Dizziness
|
20.0%
5/25 • Number of events 5 • 2 years
|
|
General disorders
Dry Mouth
|
20.0%
5/25 • Number of events 5 • 2 years
|
|
General disorders
Dry Skin
|
16.0%
4/25 • Number of events 5 • 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
16.0%
4/25 • Number of events 5 • 2 years
|
|
Ear and labyrinth disorders
Ear Wound
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Ear pain
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Edema
|
12.0%
3/25 • Number of events 3 • 2 years
|
|
Endocrine disorders
Endocrine Disorders
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
General disorders
epistaxis
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Esophagitis
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Eye disorders
Sore Eyes
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Fatigue
|
64.0%
16/25 • Number of events 28 • 2 years
|
|
Infections and infestations
Fever
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
General disorders
Flank Pain
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Flu like Symptoms
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Cardiac disorders
Flushing
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Gait disturbance
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Gastritis
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Loose Stools
|
12.0%
3/25 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Small Bowel obstruction
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal discomfort
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea without Vomiting
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Odynophagia
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Sinus Congestion
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Reduced Stamina
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Decreased Appetite
|
12.0%
3/25 • Number of events 3 • 2 years
|
|
General disorders
Night Sweats
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Runny Nose
|
4.0%
1/25 • Number of events 2 • 2 years
|
|
General disorders
Dry lips
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Elevated PSA
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Pneumomesentery
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Headache
|
80.0%
20/25 • Number of events 46 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Hemorrhoids
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Elevated Liver Enzymes
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Portal Vein/Hepatic Thrombosis
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
LFT Elevation
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Hepatobiliary disorders
Transaminitis
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Hot Flashes
|
4.0%
1/25 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
4.0%
1/25 • Number of events 2 • 2 years
|
|
Endocrine disorders
Hyperglycemia
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
Vascular disorders
Hypoalbuminemia
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Hypokalemia
|
8.0%
2/25 • Number of events 3 • 2 years
|
|
General disorders
Hyponatremia
|
4.0%
1/25 • Number of events 3 • 2 years
|
|
Cardiac disorders
Hypotension
|
4.0%
1/25 • Number of events 2 • 2 years
|
|
Infections and infestations
COVID-19
|
12.0%
3/25 • Number of events 3 • 2 years
|
|
Injury, poisoning and procedural complications
Head Injury
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Insomnia
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
General disorders
Intracranial Hemorrhage
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
General disorders
Libido decreased
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Lymphocyte Count Decreased
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus Type II
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Loss of Weight
|
12.0%
3/25 • Number of events 3 • 2 years
|
|
Skin and subcutaneous tissue disorders
Oral Mucositis
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.0%
1/25 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Left Inguinal pain
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest Tightness
|
8.0%
2/25 • Number of events 5 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest Tingles
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Penis Tingles
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Soreness in Penis
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Right Upper Quadrant Discomfort
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica Symptoms
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
General disorders
Nausea
|
32.0%
8/25 • Number of events 15 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma
|
8.0%
2/25 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Oral Pain
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporsis
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain
|
16.0%
4/25 • Number of events 5 • 2 years
|
|
Cardiac disorders
Palipations
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Eye disorders
Photosensitivity
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Platelet Count Decreased
|
4.0%
1/25 • Number of events 5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
2/25 • Number of events 3 • 2 years
|
|
Psychiatric disorders
Forgetfulness
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
4.0%
1/25 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
28.0%
7/25 • Number of events 11 • 2 years
|
|
Renal and urinary disorders
Enlarged Prostate
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Scrotal Infection
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Nervous system disorders
Seizure
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Infections and infestations
Sinusitis
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry desquamation
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Generalized Itchy Rash
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Left Chest Papule of Unknown Origin
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Xerosis over BUE
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Tinea Pedis - Bilateral
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
pruritis on Abdomen
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Desquamation - Scalp
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Fingers Peeling
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erythematous Rash on Trunk
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erythematous Rash on Back
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar/plantar xeroderma
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Infections and infestations
Skin Infection
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
Post-Operative Dental Pain
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
General disorders
Tinnituts
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Infections and infestations
Tooth infection
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Nervous system disorders
Tremor
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory infection
|
8.0%
2/25 • Number of events 2 • 2 years
|
|
Infections and infestations
Urinary Tract infection
|
16.0%
4/25 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
28.0%
7/25 • Number of events 9 • 2 years
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
4.0%
1/25 • Number of events 3 • 2 years
|
|
Renal and urinary disorders
Acute urinary Retention
|
4.0%
1/25 • Number of events 1 • 2 years
|
|
Eye disorders
Right Eye Stye
|
4.0%
1/25 • Number of events 1 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place