Trial Outcomes & Findings for Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT02122185)
NCT ID: NCT02122185
Last Updated: 2026-03-27
Results Overview
Time to disease progression or death from any cause. Progression evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and Gynecological Cancer Intergroup (GCIG) criteria. For example, progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
Up to 6 years
Results posted on
2026-03-27
Participant Flow
Participant milestones
| Measure |
Metformin Plus Chemotherapy
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given PO
Chemotherapy: Participants will received standard chemotherapy (6-8 cycles). Specific regimen to be given is at the discretion of their treating physician.
|
Placebo Plus Chemotherapy
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
Chemotherapy: Participants will received standard chemotherapy (6-8 cycles). Specific regimen to be given is at the discretion of their treating physician.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
55
|
|
Overall Study
COMPLETED
|
54
|
54
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Metformin Plus Chemotherapy
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given PO
Chemotherapy: Participants will received standard chemotherapy (6-8 cycles). Specific regimen to be given is at the discretion of their treating physician.
|
Placebo Plus Chemotherapy
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
Chemotherapy: Participants will received standard chemotherapy (6-8 cycles). Specific regimen to be given is at the discretion of their treating physician.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
One patient had missing age in the metformin arm.
Baseline characteristics by cohort
| Measure |
Metformin Plus Chemotherapy
n=54 Participants
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
Placebo Plus Chemotherapy
n=54 Participants
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 10.6 • n=53 Participants • One patient had missing age in the metformin arm.
|
63.7 years
STANDARD_DEVIATION 10.2 • n=54 Participants • One patient had missing age in the metformin arm.
|
63.9 years
STANDARD_DEVIATION 10.4 • n=107 Participants • One patient had missing age in the metformin arm.
|
|
Sex: Female, Male
Female
|
54 Participants
n=54 Participants
|
54 Participants
n=54 Participants
|
108 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
3 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=54 Participants
|
7 Participants
n=54 Participants
|
14 Participants
n=108 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=54 Participants
|
42 Participants
n=54 Participants
|
85 Participants
n=108 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=54 Participants
|
4 Participants
n=54 Participants
|
6 Participants
n=108 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=54 Participants
|
54 participants
n=54 Participants
|
108 participants
n=108 Participants
|
PRIMARY outcome
Timeframe: Up to 6 yearsTime to disease progression or death from any cause. Progression evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 and Gynecological Cancer Intergroup (GCIG) criteria. For example, progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Metformin Plus Chemotherapy
n=54 Participants
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
Placebo Plus Chemotherapy
n=54 Participants
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
15.4 Months
Interval 11.2 to 23.5
|
14.3 Months
Interval 11.6 to 18.0
|
SECONDARY outcome
Timeframe: Up to 6 yearsCA125 progression determined using GCIG criteria. Radiological progression assessed using RECIST criteria as described above for PFS. For example, progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Metformin Plus Chemotherapy
n=54 Participants
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
Placebo Plus Chemotherapy
n=54 Participants
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
|---|---|---|
|
Time to Biochemical (CA-125) Progression, Radiological Progression, or Death.
|
14.4 Months
Interval 11.0 to 17.1
|
13.7 Months
Interval 11.5 to 17.9
|
SECONDARY outcome
Timeframe: Up to 6 yearsTime from randomization to death.
Outcome measures
| Measure |
Metformin Plus Chemotherapy
n=54 Participants
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
Placebo Plus Chemotherapy
n=54 Participants
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
|---|---|---|
|
Overall Survival
|
40.7 Months
Interval 28.0 to 48.2
|
43.8 Months
Interval 35.3 to 57.2
|
SECONDARY outcome
Timeframe: Up to 6 yearsGrade 3 or higher serious adverse event. Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Outcome measures
| Measure |
Metformin Plus Chemotherapy
n=54 Participants
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
Placebo Plus Chemotherapy
n=54 Participants
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
19 Participants
|
13 Participants
|
Adverse Events
Metformin Plus Chemotherapy
Serious events: 19 serious events
Other events: 52 other events
Deaths: 31 deaths
Placebo Plus Chemotherapy
Serious events: 13 serious events
Other events: 54 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Metformin Plus Chemotherapy
n=54 participants at risk
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
Placebo Plus Chemotherapy
n=54 participants at risk
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
|---|---|---|
|
Infections and infestations
Abdominal infection
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Immune system disorders
Allergic reaction
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
1/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
1.9%
1/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Infections and infestations
Wound infection
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
General disorders
Fever
|
0.00%
0/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Nervous system disorders
Headache
|
0.00%
0/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
General disorders
Infusion related reaction
|
0.00%
0/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Infections and infestations
Meningitis
|
0.00%
0/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Psychiatric disorders
Confusion
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
2/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
1/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
3/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
General disorders
Fatigue
|
1.9%
1/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.3%
5/54 • 6 years
|
3.7%
2/54 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.9%
1/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Vascular disorders
Hypotension
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Infections and infestations
Kidney infection
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Infections and infestations
Lung infection
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Investigations
Lymphocyte count decreased
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/54 • 6 years
|
3.7%
2/54 • 6 years
|
|
Investigations
Neutrophil count decreased
|
7.4%
4/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Investigations
Platelet count decreased
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
7.4%
4/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Gastrointestinal disorders
Small intestinal perforation
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Nervous system disorders
Syncope
|
3.7%
2/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Vascular disorders
Thromboembolic event
|
3.7%
2/54 • 6 years
|
3.7%
2/54 • 6 years
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
2/54 • 6 years
|
3.7%
2/54 • 6 years
|
|
Investigations
White blood cell decreased
|
3.7%
2/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Surgical and medical procedures
Surgical and medical procedures - other
|
0.00%
0/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Gastrointestinal disorders
Ileus
|
1.9%
1/54 • 6 years
|
0.00%
0/54 • 6 years
|
Other adverse events
| Measure |
Metformin Plus Chemotherapy
n=54 participants at risk
Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
metformin hydrochloride: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
Placebo Plus Chemotherapy
n=54 participants at risk
Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
|
|---|---|---|
|
Nervous system disorders
Headache
|
22.2%
12/54 • 6 years
|
18.5%
10/54 • 6 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.6%
3/54 • 6 years
|
3.7%
2/54 • 6 years
|
|
Vascular disorders
Hypertension
|
16.7%
9/54 • 6 years
|
18.5%
10/54 • 6 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
9/54 • 6 years
|
14.8%
8/54 • 6 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
6/54 • 6 years
|
7.4%
4/54 • 6 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
35.2%
19/54 • 6 years
|
29.6%
16/54 • 6 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
35.2%
19/54 • 6 years
|
18.5%
10/54 • 6 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
9/54 • 6 years
|
9.3%
5/54 • 6 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
14.8%
8/54 • 6 years
|
14.8%
8/54 • 6 years
|
|
Vascular disorders
Hypotension
|
5.6%
3/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Psychiatric disorders
Insomnia
|
18.5%
10/54 • 6 years
|
18.5%
10/54 • 6 years
|
|
Investigations
Lymphocyte count decreased
|
9.3%
5/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Nervous system disorders
Memory impairment
|
5.6%
3/54 • 6 years
|
5.6%
3/54 • 6 years
|
|
Gastrointestinal disorders
Mucositis oral
|
7.4%
4/54 • 6 years
|
20.4%
11/54 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.4%
11/54 • 6 years
|
31.5%
17/54 • 6 years
|
|
Gastrointestinal disorders
Nausea
|
72.2%
39/54 • 6 years
|
70.4%
38/54 • 6 years
|
|
Investigations
Neutrophil count decreased
|
61.1%
33/54 • 6 years
|
57.4%
31/54 • 6 years
|
|
Infections and infestations
Skin infection
|
1.9%
1/54 • 6 years
|
5.6%
3/54 • 6 years
|
|
Renal and urinary disorders
Urinary frequency
|
1.9%
1/54 • 6 years
|
7.4%
4/54 • 6 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/54 • 6 years
|
5.6%
3/54 • 6 years
|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
3/54 • 6 years
|
3.7%
2/54 • 6 years
|
|
Gastrointestinal disorders
Abdominal pain
|
31.5%
17/54 • 6 years
|
37.0%
20/54 • 6 years
|
|
Gastrointestinal disorders
Constipation
|
40.7%
22/54 • 6 years
|
63.0%
34/54 • 6 years
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
4/54 • 6 years
|
7.4%
4/54 • 6 years
|
|
Gastrointestinal disorders
Flatulence
|
9.3%
5/54 • 6 years
|
7.4%
4/54 • 6 years
|
|
Skin and subcutaneous tissue disorders
Rash maculao-papular
|
11.1%
6/54 • 6 years
|
24.1%
13/54 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
6/54 • 6 years
|
14.8%
8/54 • 6 years
|
|
Cardiac disorders
Palpitations
|
5.6%
3/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.4%
4/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.6%
3/54 • 6 years
|
5.6%
3/54 • 6 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
27/54 • 6 years
|
66.7%
36/54 • 6 years
|
|
Investigations
Platelet count decreased
|
42.6%
23/54 • 6 years
|
51.9%
28/54 • 6 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders - other
|
5.6%
3/54 • 6 years
|
1.9%
1/54 • 6 years
|
|
Infections and infestations
Urinary tract infection
|
16.7%
9/54 • 6 years
|
11.1%
6/54 • 6 years
|
|
Gastrointestinal disorders
Vomiting
|
42.6%
23/54 • 6 years
|
27.8%
15/54 • 6 years
|
|
Investigations
Weight gain
|
7.4%
4/54 • 6 years
|
24.1%
13/54 • 6 years
|
|
Investigations
Weight loss
|
38.9%
21/54 • 6 years
|
27.8%
15/54 • 6 years
|
|
Investigations
White blood cell decreased
|
59.3%
32/54 • 6 years
|
53.7%
29/54 • 6 years
|
|
General disorders
Chills
|
3.7%
2/54 • 6 years
|
5.6%
3/54 • 6 years
|
|
Investigations
Creatinine increased
|
16.7%
9/54 • 6 years
|
5.6%
3/54 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/54 • 6 years
|
7.4%
4/54 • 6 years
|
|
Vascular disorders
Hot flashes
|
3.7%
2/54 • 6 years
|
16.7%
9/54 • 6 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
3/54 • 6 years
|
9.3%
5/54 • 6 years
|
|
General disorders
Infusion related reaction
|
1.9%
1/54 • 6 years
|
5.6%
3/54 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.9%
1/54 • 6 years
|
5.6%
3/54 • 6 years
|
|
Gastrointestinal disorders
Non-cardiac chest pain
|
3.7%
2/54 • 6 years
|
5.6%
3/54 • 6 years
|
|
General disorders
Pain
|
3.7%
2/54 • 6 years
|
9.3%
5/54 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.5%
10/54 • 6 years
|
13.0%
7/54 • 6 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
5.6%
3/54 • 6 years
|
0.00%
0/54 • 6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
3/54 • 6 years
|
3.7%
2/54 • 6 years
|
|
Psychiatric disorders
Depression
|
7.4%
4/54 • 6 years
|
16.7%
9/54 • 6 years
|
|
Gastrointestinal disorders
Diarrhea
|
59.3%
32/54 • 6 years
|
55.6%
30/54 • 6 years
|
|
Gastrointestinal disorders
Bloating
|
24.1%
13/54 • 6 years
|
22.2%
12/54 • 6 years
|
|
Nervous system disorders
Dizziness
|
13.0%
7/54 • 6 years
|
18.5%
10/54 • 6 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.0%
7/54 • 6 years
|
9.3%
5/54 • 6 years
|
|
Nervous system disorders
Dysgeusia
|
25.9%
14/54 • 6 years
|
25.9%
14/54 • 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
12/54 • 6 years
|
27.8%
15/54 • 6 years
|
|
Gastrointestinal disorders
Edema limbs
|
14.8%
8/54 • 6 years
|
20.4%
11/54 • 6 years
|
|
Gastrointestinal disorders
Fatigue
|
63.0%
34/54 • 6 years
|
74.1%
40/54 • 6 years
|
|
General disorders
Fever
|
5.6%
3/54 • 6 years
|
5.6%
3/54 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.8%
8/54 • 6 years
|
13.0%
7/54 • 6 years
|
|
Investigations
Alanine aminotransferase (ALT) increased
|
16.7%
9/54 • 6 years
|
16.7%
9/54 • 6 years
|
|
Investigations
Alkaline phosphatase increased
|
7.4%
4/54 • 6 years
|
13.0%
7/54 • 6 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
64.8%
35/54 • 6 years
|
77.8%
42/54 • 6 years
|
|
Blood and lymphatic system disorders
Anemia
|
75.9%
41/54 • 6 years
|
81.5%
44/54 • 6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
27/54 • 6 years
|
38.9%
21/54 • 6 years
|
|
Psychiatric disorders
Anxiety
|
9.3%
5/54 • 6 years
|
13.0%
7/54 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.3%
5/54 • 6 years
|
20.4%
11/54 • 6 years
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
9/54 • 6 years
|
9.3%
5/54 • 6 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.0%
7/54 • 6 years
|
14.8%
8/54 • 6 years
|
|
Eye disorders
Blurred vision
|
5.6%
3/54 • 6 years
|
9.3%
5/54 • 6 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place