Trial Outcomes & Findings for Perioperative Chemo and Pembrolizumab in Gastric Cancer (NCT NCT02918162)
NCT ID: NCT02918162
Last Updated: 2024-02-15
Results Overview
Number of subjects with absence of viable tumor on surgical resection specimen as determined by local pathology review.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Up to 34 months
Results posted on
2024-02-15
Participant Flow
49 participants signed a consent form, 10 of which were screen failures and 3 of which withdrew consent prior to completion of screening.
Participant milestones
| Measure |
Pembrolizumab
All study subjects will receive standard of care chemotherapy regimen for 3 cycles prior to and 3 cycles following surgery in combination with Pembrolizumab with an additional cycle of Pembrolizumab (4 total) in the pre-operative period. Additionally subjects will complete 12 months of maintenance Pembrolizumab (14 additional doses to complete 17 post-operative cycles) following completion of post-operative chemotherapy.
Standard of care combination chemotherapy regimen has a 21-day cycle.
Pembrolizumab: Pembrolizumab dosed IV at 200mg every 21 days per cycle.
Standard of care chemotherapy regimen: Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician.
Example:
Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Pembrolizumab
All study subjects will receive standard of care chemotherapy regimen for 3 cycles prior to and 3 cycles following surgery in combination with Pembrolizumab with an additional cycle of Pembrolizumab (4 total) in the pre-operative period. Additionally subjects will complete 12 months of maintenance Pembrolizumab (14 additional doses to complete 17 post-operative cycles) following completion of post-operative chemotherapy.
Standard of care combination chemotherapy regimen has a 21-day cycle.
Pembrolizumab: Pembrolizumab dosed IV at 200mg every 21 days per cycle.
Standard of care chemotherapy regimen: Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician.
Example:
Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Omental Disease
|
1
|
Baseline Characteristics
Perioperative Chemo and Pembrolizumab in Gastric Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=34 Participants
All study subjects will receive standard of care chemotherapy regimen for 3 cycles prior to and 3 cycles following surgery in combination with Pembrolizumab with an additional cycle of Pembrolizumab (4 total) in the pre-operative period. Additionally subjects will complete 12 months of maintenance Pembrolizumab (14 additional doses to complete 17 post-operative cycles) following completion of post-operative chemotherapy.
Standard of care combination chemotherapy regimen has a 21-day cycle.
Pembrolizumab: Pembrolizumab dosed IV at 200mg every 21 days per cycle.
Standard of care chemotherapy regimen: Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician.
Example:
Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 34 monthsNumber of subjects with absence of viable tumor on surgical resection specimen as determined by local pathology review.
Outcome measures
| Measure |
Pembrolizumab
n=34 Participants
All study subjects will receive standard of care chemotherapy regimen for 3 cycles prior to and 3 cycles following surgery in combination with Pembrolizumab with an additional cycle of Pembrolizumab (4 total) in the pre-operative period. Additionally subjects will complete 12 months of maintenance Pembrolizumab (14 additional doses to complete 17 post-operative cycles) following completion of post-operative chemotherapy.
Standard of care combination chemotherapy regimen has a 21-day cycle.
Pembrolizumab: Pembrolizumab dosed IV at 200mg every 21 days per cycle.
Standard of care chemotherapy regimen: Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician.
Example:
Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily.
|
|---|---|
|
Pathologic Complete Response (pCR) Rate
|
7 Participants
|
SECONDARY outcome
Timeframe: Treatment initiation until death or study end, whichever occurs first (up to approximately 5 years)OS defined as the time from Cyle 1 Day 1 treatment administration to death due to any cause. The 24 month overall survival probability was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Pembrolizumab
n=34 Participants
All study subjects will receive standard of care chemotherapy regimen for 3 cycles prior to and 3 cycles following surgery in combination with Pembrolizumab with an additional cycle of Pembrolizumab (4 total) in the pre-operative period. Additionally subjects will complete 12 months of maintenance Pembrolizumab (14 additional doses to complete 17 post-operative cycles) following completion of post-operative chemotherapy.
Standard of care combination chemotherapy regimen has a 21-day cycle.
Pembrolizumab: Pembrolizumab dosed IV at 200mg every 21 days per cycle.
Standard of care chemotherapy regimen: Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician.
Example:
Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily.
|
|---|---|
|
Overall Survival (OS)
|
80.6 Probability
Interval 67.6 to 96.1
|
SECONDARY outcome
Timeframe: Treatment initiation to progression, recurrence, death or study end, whichever comes first (up to approximately 5 years)DFS defined as time from Cycle 1 Day 1 treatment administration to the first documented event of disease progression, disease recurrence following surgery (preferably biopsy proven), or death whichever occurs first. The 24 month DFS probability was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Pembrolizumab
n=34 Participants
All study subjects will receive standard of care chemotherapy regimen for 3 cycles prior to and 3 cycles following surgery in combination with Pembrolizumab with an additional cycle of Pembrolizumab (4 total) in the pre-operative period. Additionally subjects will complete 12 months of maintenance Pembrolizumab (14 additional doses to complete 17 post-operative cycles) following completion of post-operative chemotherapy.
Standard of care combination chemotherapy regimen has a 21-day cycle.
Pembrolizumab: Pembrolizumab dosed IV at 200mg every 21 days per cycle.
Standard of care chemotherapy regimen: Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician.
Example:
Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily.
|
|---|---|
|
Disease Free Survival (DFS)
|
67.8 Probability
Interval 53.1 to 86.6
|
SECONDARY outcome
Timeframe: Up to 34 monthsNumber of subjects with initial RECIST 1.1 measurable disease who have complete response (CR) or partial response (PR) at any time (ORR= CR + PR). CR defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Pembrolizumab
n=34 Participants
All study subjects will receive standard of care chemotherapy regimen for 3 cycles prior to and 3 cycles following surgery in combination with Pembrolizumab with an additional cycle of Pembrolizumab (4 total) in the pre-operative period. Additionally subjects will complete 12 months of maintenance Pembrolizumab (14 additional doses to complete 17 post-operative cycles) following completion of post-operative chemotherapy.
Standard of care combination chemotherapy regimen has a 21-day cycle.
Pembrolizumab: Pembrolizumab dosed IV at 200mg every 21 days per cycle.
Standard of care chemotherapy regimen: Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician.
Example:
Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily.
|
|---|---|
|
Overall Response Rate (ORR)
|
14 Participants
|
Adverse Events
Pembrolizumab
Serious events: 9 serious events
Other events: 35 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=35 participants at risk
All study subjects will receive standard of care chemotherapy regimen for 3 cycles prior to and 3 cycles following surgery in combination with Pembrolizumab with an additional cycle of Pembrolizumab (4 total) in the pre-operative period. Additionally subjects will complete 12 months of maintenance Pembrolizumab (14 additional doses to complete 17 post-operative cycles) following completion of post-operative chemotherapy.
Standard of care combination chemotherapy regimen has a 21-day cycle.
Pembrolizumab: Pembrolizumab dosed IV at 200mg every 21 days per cycle.
Standard of care chemotherapy regimen: Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician.
Example:
Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
17.1%
6/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Infections and infestations
Sepsis
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Gastric perforation
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Infections and infestations
Lung infection
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
Other adverse events
| Measure |
Pembrolizumab
n=35 participants at risk
All study subjects will receive standard of care chemotherapy regimen for 3 cycles prior to and 3 cycles following surgery in combination with Pembrolizumab with an additional cycle of Pembrolizumab (4 total) in the pre-operative period. Additionally subjects will complete 12 months of maintenance Pembrolizumab (14 additional doses to complete 17 post-operative cycles) following completion of post-operative chemotherapy.
Standard of care combination chemotherapy regimen has a 21-day cycle.
Pembrolizumab: Pembrolizumab dosed IV at 200mg every 21 days per cycle.
Standard of care chemotherapy regimen: Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician.
Example:
Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
57.1%
20/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
General disorders
Fatigue
|
65.7%
23/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
57.1%
20/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Nausea
|
54.3%
19/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.4%
11/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Vomitting
|
31.4%
11/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Investigations
Neutrophil count decreased
|
28.6%
10/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Blood and lymphatic system disorders
Anemia
|
25.7%
9/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.9%
8/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
20.0%
7/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
7/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.1%
6/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
5/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
5/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.4%
4/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Mucositis oral
|
11.4%
4/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Investigations
Platelet count decreased
|
11.4%
4/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Endocrine disorders
Adrenal insufficiency
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
3/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
General disorders
Chills
|
8.6%
3/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Constipation
|
8.6%
3/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Dizziness
|
8.6%
3/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Dry mouth
|
8.6%
3/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.6%
3/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Headache
|
8.6%
3/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Paresthesia
|
8.6%
3/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.6%
3/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.6%
3/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Investigations
Weight loss
|
8.6%
3/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Immune system disorders
Allergic reaction
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Bloating
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Colitis
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
General disorders
Flu like symptoms
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Endocrine disorders
Hyperthyroidism
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Vascular disorders
Hypotension
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
General disorders
Pain
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Investigations
White blood cell decreased
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Investigations
Alkaline phosphatase increased
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Skin and subcutaneous tissue disorders
Body odor
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Cognitive disturbance
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Concentration impairment
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Confusion
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Dysarthria
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Dysesthesia
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Dysgeusia
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
General disorders
Edema face
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
General disorders
Fever
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Vascular disorders
Flushing
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
General disorders
Gait disturbance
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Psychiatric disorders
Hallucinations
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Vascular disorders
Hot flashes
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
General disorders
Infusion related reaction
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Memory impairment
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Presyncope
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Tremor
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Infections and infestations
Upper respiratory infection
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Renal and urinary disorders
Urinary frequency
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.7%
2/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Infections and infestations
Sepsis
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Syncope
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorder
|
17.1%
6/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Endocrine disorders
Endocrine Disorder
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Cardiac disorders
Cardiac Disorder
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Infections and infestations
Infection and Infestation
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Nervous system disorders
Cold Sensitivity
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Surgical and medical procedures
Surgical and Medical Procedure
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Cramping
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Gastrointestinal disorders
Pseudo laryngospasm
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.9%
1/35 • Up to 34 months
Systematic assessment of adverse events: Routine review of and for adverse events at each scheduled visit through investigator assessment and laboratory testing. 36 participants enrolled in the study, one participant withdrew consent, therefore 35 were included in adverse events assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place