Trial Outcomes & Findings for Pembrolizumab, Standard Chemotherapy, Tumor Infiltrating Lymphocytes, and High- or Low-Dose Aldesleukin in Treating Patients With Metastatic Melanoma (NCT NCT02500576)
NCT ID: NCT02500576
Last Updated: 2025-01-15
Results Overview
The overall response rate will be computed separately by arm and presented with exact 95% confidence intervals. The overall response rate will be compared between the two treatment arms by using Fisher's exact test. The association between overall response rate and the same covariates will be assessed by using logistic regression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2025-01-15
Participant Flow
A phase II randomized stuy for patients with lymphodepletion, ex-vivo expanded melanoma. Patients with prior surgical excission of a melanoma tumor from the outpatient clinic based on tumor size.
18 participants consented and off-study; 16 participants treated, 1-participant was not eligible and not assigned an arm, 1-participant withdrew due to denial of insurance.
Participant milestones
| Measure |
Arm 1-High Dose IL2
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion, Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0 TIL infusion; Day +1 - HD I2, 720,00IU/kg IV bolus q 8-16 hrs up to 15 doses, approx 12-16 hrs post T-cell Infusion; Day +22 MK-3475 200 mg IV
|
Arm 2- Low Dose IL2
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion- Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0- TIL infustion; Da +1-+14: LD IL-2, 2 million IU SC bolus daily x 14 days approx 6 hrs post T-cell infusion; Day =22 MK-3475 200mg IV
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
| Measure |
Arm 1-High Dose IL2
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion, Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0 TIL infusion; Day +1 - HD I2, 720,00IU/kg IV bolus q 8-16 hrs up to 15 doses, approx 12-16 hrs post T-cell Infusion; Day +22 MK-3475 200 mg IV
|
Arm 2- Low Dose IL2
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion- Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0- TIL infustion; Da +1-+14: LD IL-2, 2 million IU SC bolus daily x 14 days approx 6 hrs post T-cell infusion; Day =22 MK-3475 200mg IV
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Pembrolizumab, Standard Chemotherapy, Tumor Infiltrating Lymphocytes, and High- or Low-Dose Aldesleukin in Treating Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Arm 1- High Dose IL2
n=8 Participants
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion, Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0 TIL infusion; Day +1 - HD I2, 720,00IU/kg IV bolus q 8-16 hrs up to 15 doses, approx 12-16 hrs post T-cell Infusion; Day +22 MK-3475 200 mg IV
|
Arm 2- High Dose IL2
n=8 Participants
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion- Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0- TIL infustion; Da +1-+14: LD IL-2, 2 million IU SC bolus daily x 14 days approx 6 hrs post T-cell infusion; Day =22 MK-3475 200mg IV
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 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
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 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
|
8 participants
n=99 Participants
|
8 participants
n=107 Participants
|
16 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsThe overall response rate will be computed separately by arm and presented with exact 95% confidence intervals. The overall response rate will be compared between the two treatment arms by using Fisher's exact test. The association between overall response rate and the same covariates will be assessed by using logistic regression.
Outcome measures
| Measure |
Arm 1
n=7 Participants
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion, Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0 TIL infusion; Day +1 - HD I2, 720,00IU/kg IV bolus q 8-16 hrs up to 15 doses, approx 12-16 hrs post T-cell Infusion; Day +22 MK-3475 200 mg IV
|
Arm 2
n=7 Participants
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion- Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0- TIL infustion; Da +1-+14: LD IL-2, 2 million IU SC bolus daily x 14 days approx 6 hrs post T-cell infusion; Day =22 MK-3475 200mg IV
|
|---|---|---|
|
Overall Response Rate in Each Arm
Partial Response
|
1 Participants
|
1 Participants
|
|
Overall Response Rate in Each Arm
Stable Disease
|
2 Participants
|
1 Participants
|
|
Overall Response Rate in Each Arm
Progressive Disease
|
3 Participants
|
5 Participants
|
|
Overall Response Rate in Each Arm
Not Evaluable
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe method of Kaplan and Meier will be used to estimate the distributions of overall survival and distributions will be compared between arms by using the log-rank test. Cox regression analysis will be used to assess the association between disease and clinical covariates of interest and overall survival.
Outcome measures
| Measure |
Arm 1
n=7 Participants
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion, Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0 TIL infusion; Day +1 - HD I2, 720,00IU/kg IV bolus q 8-16 hrs up to 15 doses, approx 12-16 hrs post T-cell Infusion; Day +22 MK-3475 200 mg IV
|
Arm 2
n=7 Participants
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion- Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0- TIL infustion; Da +1-+14: LD IL-2, 2 million IU SC bolus daily x 14 days approx 6 hrs post T-cell infusion; Day =22 MK-3475 200mg IV
|
|---|---|---|
|
Overall Survival
|
9.7 months
Interval 3.0 to
The upper limit of the confidence interval is not estimable because of the small number of patients.
|
8.8 months
Interval 8.2 to
The upper limit of the confidence interval is not estimable because of the small number of patients.
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe method of Kaplan and Meier will be used to estimate the distributions of progression-free survival, and distributions will be compared between arms by using the log-rank test. Cox regression analysis will be used to assess the association between disease and clinical covariates of interest and progression-free survival.
Outcome measures
| Measure |
Arm 1
n=7 Participants
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion, Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0 TIL infusion; Day +1 - HD I2, 720,00IU/kg IV bolus q 8-16 hrs up to 15 doses, approx 12-16 hrs post T-cell Infusion; Day +22 MK-3475 200 mg IV
|
Arm 2
n=7 Participants
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion- Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0- TIL infustion; Da +1-+14: LD IL-2, 2 million IU SC bolus daily x 14 days approx 6 hrs post T-cell infusion; Day =22 MK-3475 200mg IV
|
|---|---|---|
|
Progression-free Survival
|
28.6 months
Interval 8.9 to 92.2
|
14.3 months
Interval 2.3 to 87.7
|
SECONDARY outcome
Timeframe: Baseline and weeks 3, 6, and 9A generalized linear mixed model approach to account for intra-patient correlation will be used to measure blood and tumor biomarkers collected over time.
Outcome measures
| Measure |
Arm 1
n=4 Participants
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion, Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0 TIL infusion; Day +1 - HD I2, 720,00IU/kg IV bolus q 8-16 hrs up to 15 doses, approx 12-16 hrs post T-cell Infusion; Day +22 MK-3475 200 mg IV
|
Arm 2
n=7 Participants
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion- Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0- TIL infustion; Da +1-+14: LD IL-2, 2 million IU SC bolus daily x 14 days approx 6 hrs post T-cell infusion; Day =22 MK-3475 200mg IV
|
|---|---|---|
|
Change in Blood and Tumor Biomarkers
CD4/CD8 at Baseline
|
1.96 ratio
Interval 1.38 to 2.59
|
2.63 ratio
Interval 1.03 to 4.01
|
|
Change in Blood and Tumor Biomarkers
CD4/CD8 at Day 21/Week 3
|
0.58 ratio
Interval 0.21 to 1.11
|
0.52 ratio
Interval 0.19 to 0.76
|
|
Change in Blood and Tumor Biomarkers
CD4/CD8 at Day 42/Week 6
|
0.75 ratio
Interval 0.22 to 1.42
|
0.20 ratio
Interval 0.1 to 0.27
|
|
Change in Blood and Tumor Biomarkers
CD4/CD8 at Week 9
|
0.58 ratio
Interval 0.18 to 1.29
|
0.33 ratio
Interval 0.15 to 0.79
|
|
Change in Blood and Tumor Biomarkers
CD8+/ T-reg at Baseline
|
73.4 ratio
Interval 18.0 to 205.8
|
37.19 ratio
Interval 5.3 to 97.4
|
|
Change in Blood and Tumor Biomarkers
CD8+/ T-reg at Day 21/Week 3
|
10.2 ratio
Interval 2.5 to 25.4
|
9.7 ratio
Interval 1.8 to 43.4
|
|
Change in Blood and Tumor Biomarkers
CD8+/ T-reg at Day 42/Week 6
|
26.4 ratio
Interval 2.5 to 67.1
|
30.2 ratio
Interval 8.9 to 54.2
|
|
Change in Blood and Tumor Biomarkers
CD8+/ T-reg at Week 9
|
23.9 ratio
Interval 2.8 to 36.6
|
91.6 ratio
Interval 8.8 to 492.7
|
Adverse Events
Arm 1- High Dose IL2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 2 deaths
Arm 2- Low Dose IL2
Serious events: 1 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1- High Dose IL2
n=8 participants at risk
Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0 TIL infusion; Day +1 - HD I2, 720,00IU/kg IV bolus q 8-16 hrs up to 15 doses, approx 12-16 hrs post T-cell Infusion; Day +22 MK-3475 200 mg IV
|
Arm 2- Low Dose IL2
n=8 participants at risk
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion- Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0- TIL infustion; Da +1-+14: LD IL-2, 2 million IU SC bolus daily x 14 days approx 6 hrs post T-cell infusion; Day =22 MK-3475 200mg IV
|
|---|---|---|
|
Investigations
Death
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • 7 years; 1 month
|
Other adverse events
| Measure |
Arm 1- High Dose IL2
n=8 participants at risk
Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0 TIL infusion; Day +1 - HD I2, 720,00IU/kg IV bolus q 8-16 hrs up to 15 doses, approx 12-16 hrs post T-cell Infusion; Day +22 MK-3475 200 mg IV
|
Arm 2- Low Dose IL2
n=8 participants at risk
8 wks prior to screening- TIL harvest; 7 days prior to TIL infusion- Lymphodepleting chemotherapy with fludarabine and cyclophosphamide; Day 0- TIL infustion; Da +1-+14: LD IL-2, 2 million IU SC bolus daily x 14 days approx 6 hrs post T-cell infusion; Day =22 MK-3475 200mg IV
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
37.5%
3/8 • Number of events 3 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Gastrointestinal disorders
Abdominal Pain
|
37.5%
3/8 • Number of events 4 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Abrasion
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Investigations
Activated Partioal thrombopllastin time prolonged
|
75.0%
6/8 • Number of events 9 • 7 years; 1 month
|
25.0%
2/8 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Investigations
Alamine Aminotransferase Increased
|
50.0%
4/8 • Number of events 10 • 7 years; 1 month
|
37.5%
3/8 • Number of events 9 • 7 years; 1 month
|
|
Investigations
Alkaline Phosphatase Increased
|
50.0%
4/8 • Number of events 6 • 7 years; 1 month
|
62.5%
5/8 • Number of events 16 • 7 years; 1 month
|
|
Immune system disorders
Allergic Reaction
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/8 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
87.5%
7/8 • Number of events 13 • 7 years; 1 month
|
62.5%
5/8 • Number of events 11 • 7 years; 1 month
|
|
Blood and lymphatic system disorders
Anemia
|
87.5%
7/8 • Number of events 60 • 7 years; 1 month
|
75.0%
6/8 • Number of events 40 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Anorexia
|
87.5%
7/8 • Number of events 12 • 7 years; 1 month
|
62.5%
5/8 • Number of events 9 • 7 years; 1 month
|
|
Psychiatric disorders
Anxiety
|
62.5%
5/8 • Number of events 8 • 7 years; 1 month
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Investigations
Aspartate Aminotransferase increased
|
50.0%
4/8 • Number of events 8 • 7 years; 1 month
|
62.5%
5/8 • Number of events 9 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
50.0%
4/8 • Number of events 4 • 7 years; 1 month
|
25.0%
2/8 • Number of events 9 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Back Spasm
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Renal and urinary disorders
Bladder Spasm
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Gastrointestinal disorders
Bloating
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Investigations
Blood Bilirubin Increase
|
37.5%
3/8 • Number of events 11 • 7 years; 1 month
|
37.5%
3/8 • Number of events 8 • 7 years; 1 month
|
|
Investigations
Blood Lymphatic System Disorder
|
12.5%
1/8 • Number of events 2 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Eye disorders
Blurred Vision
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Renal and urinary disorders
BHP
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Eye disorders
Cataract
|
12.5%
1/8 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Infections and infestations
Cellulitis
|
12.5%
1/8 • 7 years; 1 month
|
12.5%
1/8 • 7 years; 1 month
|
|
Cardiac disorders
Chest-Pain
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Chills
|
87.5%
7/8 • Number of events 14 • 7 years; 1 month
|
50.0%
4/8 • Number of events 8 • 7 years; 1 month
|
|
Infections and infestations
CMV
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Eye disorders
Conjunctival Hemorrhage
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Gastrointestinal disorders
Constipation
|
75.0%
6/8 • Number of events 9 • 7 years; 1 month
|
62.5%
5/8 • Number of events 10 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
75.0%
6/8 • Number of events 9 • 7 years; 1 month
|
50.0%
4/8 • Number of events 9 • 7 years; 1 month
|
|
Investigations
CPK
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Investigations
Creatinine Increased
|
37.5%
3/8 • Number of events 5 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Dematitis
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Endocrine disorders
Diabetes Type 2
|
0.00%
0/8 • 7 years; 1 month
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Diaphoresis
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
4/8 • Number of events 5 • 7 years; 1 month
|
25.0%
2/8 • Number of events 6 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Diminished Breath Sounds
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Reproductive system and breast disorders
Diminished Lung Sounds and Crackles
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Nervous system disorders
Dizziness
|
50.0%
4/8 • Number of events 4 • 7 years; 1 month
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
|
Eye disorders
Dry Eye
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
50.0%
4/8 • Number of events 4 • 7 years; 1 month
|
25.0%
2/8 • Number of events 3 • 7 years; 1 month
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • 7 years; 1 month
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.5%
3/8 • Number of events 3 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Renal and urinary disorders
Dysuria
|
37.5%
3/8 • Number of events 4 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Investigations
Ecchymoses
|
75.0%
6/8 • Number of events 9 • 7 years; 1 month
|
50.0%
4/8 • Number of events 9 • 7 years; 1 month
|
|
General disorders
Edema (generalized)
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
General disorders
Edema Limbs
|
37.5%
3/8 • Number of events 4 • 7 years; 1 month
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
|
Gastrointestinal disorders
Epigastric Pain
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
37.5%
3/8 • Number of events 5 • 7 years; 1 month
|
|
Infections and infestations
Eye Infection
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Eye disorders
Eye Pain
|
0.00%
0/8 • 7 years; 1 month
|
50.0%
4/8 • Number of events 4 • 7 years; 1 month
|
|
Eye disorders
Eye Redness
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
62.5%
5/8 • Number of events 8 • 7 years; 1 month
|
50.0%
4/8 • Number of events 8 • 7 years; 1 month
|
|
General disorders
Fever
|
37.5%
3/8 • Number of events 6 • 7 years; 1 month
|
50.0%
4/8 • Number of events 9 • 7 years; 1 month
|
|
Social circumstances
Flatulance
|
12.5%
1/8 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Investigations
Floaters
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
General disorders
Fluid Retention
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Renal and urinary disorders
Flushing
|
0.00%
0/8 • 7 years; 1 month
|
25.0%
2/8 • Number of events 3 • 7 years; 1 month
|
|
General disorders
Fluid Overload
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
General disorders
Gait Disturbance
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 2 • 7 years; 1 month
|
|
General disorders
Generalized Edema
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Gerneralized Erythema
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
General disorders
Generalized muscle weakness
|
75.0%
6/8 • Number of events 9 • 7 years; 1 month
|
75.0%
6/8 • Number of events 7 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Granulaoma Annulare
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
General disorders
Hayfever
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 2 • 7 years; 1 month
|
|
Nervous system disorders
Head fullness
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Nervous system disorders
Headache
|
37.5%
3/8 • Number of events 5 • 7 years; 1 month
|
37.5%
3/8 • Number of events 5 • 7 years; 1 month
|
|
Ear and labyrinth disorders
Hearing Impaired
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
|
Gastrointestinal disorders
Hematemsis
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Renal and urinary disorders
Hematuria
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
12.5%
1/8 • 7 years; 1 month
|
|
General disorders
Hemorrhodial Hemorrhage
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
General disorders
Herpatic Pain
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Herpatic skin lesion
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 2 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
2/8 • Number of events 6 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
50.0%
4/8 • Number of events 5 • 7 years; 1 month
|
50.0%
4/8 • Number of events 7 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Hypernatremia
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
37.5%
3/8 • Number of events 3 • 7 years; 1 month
|
|
Endocrine disorders
Hyperthyrodism
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
87.5%
7/8 • Number of events 23 • 7 years; 1 month
|
75.0%
6/8 • Number of events 9 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
87.5%
7/8 • Number of events 17 • 7 years; 1 month
|
75.0%
6/8 • Number of events 16 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Hypokalemia
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
12.5%
1/8 • Number of events 4 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Hypomagnesenia
|
50.0%
4/8 • Number of events 5 • 7 years; 1 month
|
25.0%
2/8 • Number of events 3 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Hyponatremia
|
62.5%
5/8 • Number of events 10 • 7 years; 1 month
|
37.5%
3/8 • Number of events 5 • 7 years; 1 month
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • 7 years; 1 month
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
|
Endocrine disorders
Hypothyrodism
|
37.5%
3/8 • Number of events 3 • 7 years; 1 month
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/8 • 7 years; 1 month
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
|
Infections and infestations
Infection
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Investigations
INR Increase
|
75.0%
6/8 • Number of events 9 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
General disorders
Insomnia
|
62.5%
5/8 • Number of events 5 • 7 years; 1 month
|
12.5%
1/8 • Number of events 2 • 7 years; 1 month
|
|
Eye disorders
Iritis
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 2 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decrease
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 2 • 7 years; 1 month
|
|
Blood and lymphatic system disorders
Leukocytosis
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
12.5%
1/8 • Number of events 2 • 7 years; 1 month
|
|
Infections and infestations
Lip Infection
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
12.5%
1/8 • Number of events 2 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Vascular disorders
Lynphedema
|
0.00%
0/8 • 7 years; 1 month
|
37.5%
3/8 • Number of events 3 • 7 years; 1 month
|
|
Investigations
Lymphocyte Count Decrease
|
25.0%
2/8 • Number of events 3 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
General disorders
Malaise
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Malnutrition
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Infections and infestations
MRSA
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness- lower limbs
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Muscular Pain
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness- upper limbs
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 3 • 7 years; 1 month
|
|
General disorders
Myalgia
|
37.5%
3/8 • Number of events 5 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Cardiac disorders
Myopathy
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
2/8 • Number of events 3 • 7 years; 1 month
|
12.5%
1/8 • Number of events 2 • 7 years; 1 month
|
|
Gastrointestinal disorders
Nausea
|
75.0%
6/8 • Number of events 12 • 7 years; 1 month
|
62.5%
5/8 • Number of events 11 • 7 years; 1 month
|
|
Investigations
Neutrophil Count decreased
|
87.5%
7/8 • Number of events 26 • 7 years; 1 month
|
87.5%
7/8 • Number of events 18 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
50.0%
4/8 • Number of events 7 • 7 years; 1 month
|
|
Cardiac disorders
Non-Cardiac Chest Pain
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
25.0%
2/8 • Number of events 4 • 7 years; 1 month
|
|
General disorders
Numbness
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Gastrointestinal disorders
Oral hemorrhage
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Gastrointestinal disorders
Oral lesion
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Gastrointestinal disorders
Oral Thrush
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Pain
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
50.0%
4/8 • Number of events 5 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Pain (generalized)
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Pain (left side)
|
12.5%
1/8 • Number of events 4 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Pain (left hip)
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
12.5%
1/8 • Number of events 3 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Pain (lower back)
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Pain (right flank)
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
37.5%
3/8 • Number of events 7 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Pain ok skin
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Pallor
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Cardiac disorders
Palpitations
|
25.0%
2/8 • Number of events 2 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Papulopustular Rash
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Reproductive system and breast disorders
Pelvic Pain
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Pericardial Effusion
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
25.0%
2/8 • Number of events 3 • 7 years; 1 month
|
|
Blood and lymphatic system disorders
Petechiae
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Metabolism and nutrition disorders
Phosphorus Level Increased
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Investigations
Platelete Count Decreased
|
87.5%
7/8 • Number of events 60 • 7 years; 1 month
|
75.0%
6/8 • Number of events 36 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Post nasal drip
|
25.0%
2/8 • Number of events 3 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
87.5%
7/8 • Number of events 11 • 7 years; 1 month
|
50.0%
4/8 • Number of events 6 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Race (face)
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
2/8 • Number of events 6 • 7 years; 1 month
|
25.0%
2/8 • Number of events 4 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Rash on Truck
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Reproductive system and breast disorders
Seasonal Allergies
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi (right and middle fields)
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Right breast tenderness
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
General disorders
Right toe pain
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
General disorders
Rigors
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Seborrheic Keratosis
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Bradycardia
|
0.00%
0/8 • 7 years; 1 month
|
25.0%
2/8 • Number of events 4 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Pressure
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Tachycardia
|
50.0%
4/8 • Number of events 6 • 7 years; 1 month
|
50.0%
4/8 • Number of events 6 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
37.5%
3/8 • Number of events 3 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Skin and subcutaneous tissue disorders
Sunburn (cheecks)
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Vascular disorders
Thromboembolic event
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Gastrointestinal disorders
Thrush
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Nervous system disorders
Tingling (bil feet)
|
0.00%
0/8 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Gastrointestinal disorders
Tongue coated white
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Nervous system disorders
Tremors (Bil hands)
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
12.5%
1/8 • Number of events 2 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Renal and urinary disorders
Urinary Incontinence
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Renal and urinary disorders
Urinary Tract Infectins
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
|
Reproductive system and breast disorders
Vaginal Yeast Infections
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Cardiac disorders
Ventricular Tachycardia
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Eye disorders
Vitreous Hemorrhage
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
General disorders
Volume Overload
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8 • Number of events 6 • 7 years; 1 month
|
62.5%
5/8 • Number of events 10 • 7 years; 1 month
|
|
Eye disorders
Watery Eyes
|
12.5%
1/8 • Number of events 1 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Investigations
Weight Gain
|
50.0%
4/8 • Number of events 5 • 7 years; 1 month
|
12.5%
1/8 • Number of events 2 • 7 years; 1 month
|
|
Investigations
Weight Loss
|
37.5%
3/8 • Number of events 5 • 7 years; 1 month
|
50.0%
4/8 • Number of events 5 • 7 years; 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
50.0%
4/8 • Number of events 4 • 7 years; 1 month
|
0.00%
0/8 • 7 years; 1 month
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
75.0%
6/8 • Number of events 20 • 7 years; 1 month
|
25.0%
2/8 • Number of events 11 • 7 years; 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place