Trial Outcomes & Findings for Pembrolizumab and Combination Chemotherapy Before Surgery for the Treatment of Muscle-Invasive Bladder Cancer (NCT NCT04383743)
NCT ID: NCT04383743
Last Updated: 2025-09-18
Results Overview
Percentage of patients with no histologic evidence of tumor at time of cystectomy (ypT0N0)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
At time of radical cystectomy at approximately within 10 weeks of last neoadjuvant infusion
Results posted on
2025-09-18
Participant Flow
Participant milestones
| Measure |
Treatment (Pembrolizumab, aMVAC)
Patients receive pembrolizumab IV over 30 minutes on day 1 of weeks 0, 3, and 6 and methotrexate IV, vinblastine IV, doxorubicin IV, and cisplatin IV on day 1 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC on day 1 or 2 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy.
Cisplatin: Given IV
Doxorubicin: Given IV
Methotrexate: Given IV
Pegfilgrastim: Given SC
Pembrolizumab: Given IV
Radical Cystectomy: Undergo standard of care radical cystectomy
Vinblastine Sulfate: Given IV
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Pembrolizumab, aMVAC)
Patients receive pembrolizumab IV over 30 minutes on day 1 of weeks 0, 3, and 6 and methotrexate IV, vinblastine IV, doxorubicin IV, and cisplatin IV on day 1 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC on day 1 or 2 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy.
Cisplatin: Given IV
Doxorubicin: Given IV
Methotrexate: Given IV
Pegfilgrastim: Given SC
Pembrolizumab: Given IV
Radical Cystectomy: Undergo standard of care radical cystectomy
Vinblastine Sulfate: Given IV
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Pembrolizumab and Combination Chemotherapy Before Surgery for the Treatment of Muscle-Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab, aMVAC)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 of weeks 0, 3, and 6 and methotrexate IV, vinblastine IV, doxorubicin IV, and cisplatin IV on day 1 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC on day 1 or 2 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy.
Cisplatin: Given IV
Doxorubicin: Given IV
Methotrexate: Given IV
Pegfilgrastim: Given SC
Pembrolizumab: Given IV
Radical Cystectomy: Undergo standard of care radical cystectomy
Vinblastine Sulfate: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At time of radical cystectomy at approximately within 10 weeks of last neoadjuvant infusionPercentage of patients with no histologic evidence of tumor at time of cystectomy (ypT0N0)
Outcome measures
| Measure |
Treatment (Pembrolizumab, aMVAC)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 of weeks 0, 3, and 6 and methotrexate IV, vinblastine IV, doxorubicin IV, and cisplatin IV on day 1 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC on day 1 or 2 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy.
Cisplatin: Given IV
Doxorubicin: Given IV
Methotrexate: Given IV
Pegfilgrastim: Given SC
Pembrolizumab: Given IV
Radical Cystectomy: Undergo standard of care radical cystectomy
Vinblastine Sulfate: Given IV
|
|---|---|
|
Pathologic Complete Response Rate
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 90 days post study therapy completionThe frequency of toxicity of study therapy regimen. Measured as the number of participants that experienced an AE (any grade) related to study therapy while on trial.
Outcome measures
| Measure |
Treatment (Pembrolizumab, aMVAC)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 of weeks 0, 3, and 6 and methotrexate IV, vinblastine IV, doxorubicin IV, and cisplatin IV on day 1 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC on day 1 or 2 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy.
Cisplatin: Given IV
Doxorubicin: Given IV
Methotrexate: Given IV
Pegfilgrastim: Given SC
Pembrolizumab: Given IV
Radical Cystectomy: Undergo standard of care radical cystectomy
Vinblastine Sulfate: Given IV
|
|---|---|
|
Frequency of Any Adverse Event According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) Related to Study Therapy.
|
17 Participants
|
SECONDARY outcome
Timeframe: Up to 90 days post therapy completionThe severity of toxicity of therapy regimen. Measured as the number of participants that experienced an AE of grade 3 or higher related to study therapy while on trial
Outcome measures
| Measure |
Treatment (Pembrolizumab, aMVAC)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 of weeks 0, 3, and 6 and methotrexate IV, vinblastine IV, doxorubicin IV, and cisplatin IV on day 1 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC on day 1 or 2 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy.
Cisplatin: Given IV
Doxorubicin: Given IV
Methotrexate: Given IV
Pegfilgrastim: Given SC
Pembrolizumab: Given IV
Radical Cystectomy: Undergo standard of care radical cystectomy
Vinblastine Sulfate: Given IV
|
|---|---|
|
Frequency of Grade 3 or Greater Adverse Events According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) Related to Study Therapy.
|
8 Participants
|
SECONDARY outcome
Timeframe: At 2 yearsPercentage reported represents an estimate using the method of Kaplan-Meier 2-year EFS Estimate (95% CI)
Outcome measures
| Measure |
Treatment (Pembrolizumab, aMVAC)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 of weeks 0, 3, and 6 and methotrexate IV, vinblastine IV, doxorubicin IV, and cisplatin IV on day 1 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC on day 1 or 2 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy.
Cisplatin: Given IV
Doxorubicin: Given IV
Methotrexate: Given IV
Pegfilgrastim: Given SC
Pembrolizumab: Given IV
Radical Cystectomy: Undergo standard of care radical cystectomy
Vinblastine Sulfate: Given IV
|
|---|---|
|
Estimated 2-year Event-free Survival (EFS)
|
64 percentage of participants
Interval 32.0 to 84.0
|
SECONDARY outcome
Timeframe: within 10 weeks from completion of study therapyTo evaluate the feasibility of neoadjuvant aMVAC and pembrolizumab as measured by the rate of patients able to receive RC within 10 weeks from completion of study therapy
Outcome measures
| Measure |
Treatment (Pembrolizumab, aMVAC)
n=17 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1 of weeks 0, 3, and 6 and methotrexate IV, vinblastine IV, doxorubicin IV, and cisplatin IV on day 1 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC on day 1 or 2 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy.
Cisplatin: Given IV
Doxorubicin: Given IV
Methotrexate: Given IV
Pegfilgrastim: Given SC
Pembrolizumab: Given IV
Radical Cystectomy: Undergo standard of care radical cystectomy
Vinblastine Sulfate: Given IV
|
|---|---|
|
Number of Participants Able to Undergo Radical Cystectomy Within 10 Weeks From Completion of Study Therapy
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At time of Transurethral Bladder Tumor Resection and radical cystectomyTIL density will be summarized by means, medians, and quantiles. Changes will be evaluated as both absolute and percentage change. Descriptive statistics will also be used when needed.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Pembrolizumab, aMVAC)
Serious events: 6 serious events
Other events: 17 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Treatment (Pembrolizumab, aMVAC)
n=17 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1 of weeks 0, 3, and 6 and methotrexate IV, vinblastine IV, doxorubicin IV, and cisplatin IV on day 1 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC on day 1 or 2 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy.
Cisplatin: Given IV
Doxorubicin: Given IV
Methotrexate: Given IV
Pegfilgrastim: Given SC
Pembrolizumab: Given IV
Radical Cystectomy: Undergo standard of care radical cystectomy
Vinblastine Sulfate: Given IV
|
|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
|
General disorders
Fatigue
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis Oral
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
|
Infections and infestations
Urinary Tract Infection
|
11.8%
2/17 • Number of events 4 • Up to 2 years
|
|
Infections and infestations
Kidney Infection
|
17.6%
3/17 • Number of events 4 • Up to 2 years
|
|
General disorders
Fever
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Sinus Tachycardia
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Sepsis
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Encephalopathy
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Urinary Retention
|
5.9%
1/17 • Number of events 3 • Up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Enterocolitis Infectious
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Infections and Infestations - Other
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
Other adverse events
| Measure |
Treatment (Pembrolizumab, aMVAC)
n=17 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1 of weeks 0, 3, and 6 and methotrexate IV, vinblastine IV, doxorubicin IV, and cisplatin IV on day 1 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC on day 1 or 2 of weeks 0, 2, 4, and 6 in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care radical cystectomy.
Cisplatin: Given IV
Doxorubicin: Given IV
Methotrexate: Given IV
Pegfilgrastim: Given SC
Pembrolizumab: Given IV
Radical Cystectomy: Undergo standard of care radical cystectomy
Vinblastine Sulfate: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
|
Investigations
Alanine Aminotransferase Increased
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Investigations
Alkaline Phosphatase Increased
|
5.9%
1/17 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
52.9%
9/17 • Number of events 9 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
52.9%
9/17 • Number of events 30 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
52.9%
9/17 • Number of events 14 • Up to 2 years
|
|
Psychiatric disorders
Anxiety
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Atrial Fibrillation
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
17.6%
3/17 • Number of events 4 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
|
General disorders
Chills
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Concentration Impairment
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
64.7%
11/17 • Number of events 13 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
3/17 • Number of events 3 • Up to 2 years
|
|
Investigations
Creatinine Increased
|
23.5%
4/17 • Number of events 7 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
2/17 • Number of events 5 • Up to 2 years
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
23.5%
4/17 • Number of events 4 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
23.5%
4/17 • Number of events 4 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
47.1%
8/17 • Number of events 9 • Up to 2 years
|
|
Gastrointestinal disorders
Dyspepsia
|
47.1%
8/17 • Number of events 9 • Up to 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
|
Renal and urinary disorders
Dysuria
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
General disorders
Edema Limbs
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
General disorders
Fatigue
|
64.7%
11/17 • Number of events 11 • Up to 2 years
|
|
General disorders
Fever
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
|
Vascular disorders
Flushing
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
|
Ear and labyrinth disorders
Hearing Impaired
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
11.8%
2/17 • Number of events 2 • Up to 2 years
|
|
Vascular disorders
Hot Flashes
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.8%
2/17 • Number of events 4 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
29.4%
5/17 • Number of events 5 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
17.6%
3/17 • Number of events 4 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.5%
4/17 • Number of events 7 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis Oral
|
41.2%
7/17 • Number of events 9 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
88.2%
15/17 • Number of events 17 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Periodontal Disease
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
17.6%
3/17 • Number of events 4 • Up to 2 years
|
|
Infections and infestations
Pharyngitis
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Investigations
Platelet Count Decreased
|
17.6%
3/17 • Number of events 4 • Up to 2 years
|
|
Nervous system disorders
Presyncope
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders - Other
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Sinus Tachycardia
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Superficial Thrombophlebitis
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Thromboembolic Event
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Ear and labyrinth disorders
Tinnitus
|
35.3%
6/17 • Number of events 6 • Up to 2 years
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Urinary Frequency
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Vasculitis
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Eye disorders
Vision Decreased
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
5/17 • Number of events 6 • Up to 2 years
|
|
Gastrointestinal disorders
Stomach Pain
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Investigations
Neutrophil Count Decreased
|
11.8%
2/17 • Number of events 6 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders - Other
|
11.8%
2/17 • Number of events 3 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
17.6%
3/17 • Number of events 4 • Up to 2 years
|
|
Immune system disorders
Allergic Reaction
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
17.6%
3/17 • Number of events 3 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Bladder Infection
|
5.9%
1/17 • Number of events 4 • Up to 2 years
|
|
Nervous system disorders
Cognitive Disturbance
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Enterocolitis Infectious
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Edema
|
5.9%
1/17 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders - Other
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps) - Other
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
General disorders
Non-Cardiac Chest Pain
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.9%
1/17 • Number of events 1 • Up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place