Trial Outcomes & Findings for Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas (NCT NCT02636725)
NCT ID: NCT02636725
Last Updated: 2024-07-12
Results Overview
Percentage of participants who are disease progression free 3 months after initiation of therapy. Disease progression will be evaluated from imaging measures using the Response Evaluation Criteria for Solid Tumors (RECIST) 1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
3 Months
Results posted on
2024-07-12
Participant Flow
Participant milestones
| Measure |
Axitinib Plus Pembrolizumab Group
Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Axitinib Plus Pembrolizumab Group
Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas
Baseline characteristics by cohort
| Measure |
Axitinib Plus Pembrolizumab Group
n=33 Participants
Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
|
|---|---|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 MonthsPercentage of participants who are disease progression free 3 months after initiation of therapy. Disease progression will be evaluated from imaging measures using the Response Evaluation Criteria for Solid Tumors (RECIST) 1.1.
Outcome measures
| Measure |
Axitinib Plus Pembrolizumab Group
n=33 Participants
Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
|
|---|---|
|
Percentage of Evaluable Participants Achieving Progression-Free Survival (PFS) at 3 Months
|
81.8 percentage of participants
Interval 63.9 to 91.4
|
SECONDARY outcome
Timeframe: Up to 2 YearsPopulation: Evaluable participants received at least 80% of scheduled axitinib doses and two infusions of pembrolizumab, have measurable disease at baseline and at least one post-baseline disease assessment.
Objective Response Rate (ORR) is defined as achieving complete response (CR) or partial response (PR) from imaging measures using (RECIST) 1.1.
Outcome measures
| Measure |
Axitinib Plus Pembrolizumab Group
n=32 Participants
Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
|
|---|---|
|
Percentage of Evaluable Participants Achieving Objective Response Rate (ORR)
|
28.1 percentage of participants
Interval 13.8 to 46.8
|
SECONDARY outcome
Timeframe: Up to 2 YearsPopulation: Participants that received at least 80% of scheduled axitinib doses and two infusions of pembrolizumab, have measurable disease at baseline and at least one post-baseline disease assessment.
CBR is defined as achieving complete response (CR), partial response (PR) or stable disease (SD) from imaging measures using (RECIST) 1.1.
Outcome measures
| Measure |
Axitinib Plus Pembrolizumab Group
n=32 Participants
Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
|
|---|---|
|
Percentage of Evaluable Participants Achieving Clinical Benefit Response (CBR)
|
59.4 percentage of participants
Interval 40.6 to 76.3
|
SECONDARY outcome
Timeframe: Up to 2 yearsTime to progression (TTP) is defined as time from treatment initiation until documented disease progression according to Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1) or death (by any cause, in the absence of progression). In progression-free patients, PFS will be censored at the last evaluable tumor assessment.
Outcome measures
| Measure |
Axitinib Plus Pembrolizumab Group
n=33 Participants
Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
|
|---|---|
|
Time to Progression (TTP)
|
9.3 months
Interval 3.7 to 12.3
|
SECONDARY outcome
Timeframe: Up to 5 yearsOS is (OS) is defined as the time from treatment initiation to death from any cause, whichever is earlier. Participants alive or those lost to follow-up will be censored at the last date of contact (or last date known to be alive).
Outcome measures
| Measure |
Axitinib Plus Pembrolizumab Group
n=33 Participants
Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
|
|---|---|
|
Overall Survival (OS)
|
18.7 months
Interval 12.4 to 58.4
|
SECONDARY outcome
Timeframe: Up to 25 monthsThe number of participants experiencing serious adverse events (SAEs), dose-limiting toxicities (DLTs), and grade 3 or higher treatment-emergent adverse events (AEs). AEs, SAEs and DLTs will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Treatment-emergent adverse events are those found to be definitely, probably and possibly related to study therapy.
Outcome measures
| Measure |
Axitinib Plus Pembrolizumab Group
n=33 Participants
Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
|
|---|---|
|
Number of Participants Experiencing Serious Adverse Events (SAEs), Dose-Limiting Toxicities, and Grade 3 or Higher Treatment-Emergent Adverse Events
Serious Adverse Events (SAEs)
|
9 participants
|
|
Number of Participants Experiencing Serious Adverse Events (SAEs), Dose-Limiting Toxicities, and Grade 3 or Higher Treatment-Emergent Adverse Events
Dose Limiting Toxicities (DLTs)
|
7 participants
|
|
Number of Participants Experiencing Serious Adverse Events (SAEs), Dose-Limiting Toxicities, and Grade 3 or Higher Treatment-Emergent Adverse Events
Grade 3 or higher treatment-emergent AE (excluding SAE and DLT)
|
6 participants
|
Adverse Events
Axitinib Plus Pembrolizumab Group
Serious events: 9 serious events
Other events: 33 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Axitinib Plus Pembrolizumab Group
n=33 participants at risk
Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Investigations
Investigations - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Papulopustular rash
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Pericardial effusion
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.0%
1/33 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Radiculitis
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Seizure
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Syncope
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
Other adverse events
| Measure |
Axitinib Plus Pembrolizumab Group
n=33 participants at risk
Participants in this group will receive combination treatment of Axitinib plus Pembrolizumab for up to 2 years followed by monotherapy of Axitinib until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Axitinib: 5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
Pembrolizumab: 200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
36.4%
12/33 • Number of events 20 • Up to 5 years
|
|
Metabolism and nutrition disorders
Acidosis
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
42.4%
14/33 • Number of events 26 • Up to 5 years
|
|
Investigations
Alkaline phosphatase increased
|
30.3%
10/33 • Number of events 16 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
18.2%
6/33 • Number of events 8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
36.4%
12/33 • Number of events 27 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
39.4%
13/33 • Number of events 23 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
18.2%
6/33 • Number of events 7 • Up to 5 years
|
|
Gastrointestinal disorders
Bloating
|
6.1%
2/33 • Number of events 5 • Up to 5 years
|
|
Investigations
Blood bilirubin increased
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Breast Pain
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Chest Pain - Cardiac
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.1%
2/33 • Number of events 3 • Up to 5 years
|
|
General disorders
Chills
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
30.3%
10/33 • Number of events 11 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.4%
14/33 • Number of events 22 • Up to 5 years
|
|
Investigations
Creatinine increased
|
21.2%
7/33 • Number of events 9 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
78.8%
26/33 • Number of events 53 • Up to 5 years
|
|
Gastrointestinal disorders
Dry Mouth
|
9.1%
3/33 • Number of events 3 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.1%
4/33 • Number of events 5 • Up to 5 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
12.1%
4/33 • Number of events 4 • Up to 5 years
|
|
Ear and labyrinth disorders
Ear Pain
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
General disorders
Edema face
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
General disorders
Edema limbs
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Investigations
Ejection fraction decreased
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
General disorders
Fatigue
|
78.8%
26/33 • Number of events 56 • Up to 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
24.2%
8/33 • Number of events 8 • Up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
General disorders
General disorders and administration site conditions - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Headache
|
15.2%
5/33 • Number of events 11 • Up to 5 years
|
|
Renal and urinary disorders
Hematuria
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Investigations
Hemoglobin increased
|
15.2%
5/33 • Number of events 7 • Up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.1%
3/33 • Number of events 4 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
18.2%
6/33 • Number of events 8 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
3/33 • Number of events 4 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
42.4%
14/33 • Number of events 21 • Up to 5 years
|
|
Endocrine disorders
Hyperthyroidism
|
6.1%
2/33 • Number of events 4 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.0%
1/33 • Number of events 3 • Up to 5 years
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Endocrine disorders
Hypothyroidism
|
54.5%
18/33 • Number of events 18 • Up to 5 years
|
|
Immune system disorders
Immune system disorders - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Infections and infestations - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
Insomnia
|
15.2%
5/33 • Number of events 5 • Up to 5 years
|
|
Investigations
Investigations - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
6.1%
2/33 • Number of events 3 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis Oral
|
42.4%
14/33 • Number of events 27 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
21.2%
7/33 • Number of events 8 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
57.6%
19/33 • Number of events 33 • Up to 5 years
|
|
Nervous system disorders
Nervous system disorders - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
General disorders
Non-cardiac chest pain
|
15.2%
5/33 • Number of events 6 • Up to 5 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Oral Pain
|
9.1%
3/33 • Number of events 3 • Up to 5 years
|
|
General disorders
Pain
|
51.5%
17/33 • Number of events 22 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.2%
6/33 • Number of events 7 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
24.2%
8/33 • Number of events 11 • Up to 5 years
|
|
Infections and infestations
Papulopustular rash
|
24.2%
8/33 • Number of events 9 • Up to 5 years
|
|
Nervous system disorders
Paresthesia
|
9.1%
3/33 • Number of events 4 • Up to 5 years
|
|
Investigations
Platelet count decreased
|
9.1%
3/33 • Number of events 4 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
9.1%
3/33 • Number of events 3 • Up to 5 years
|
|
Renal and urinary disorders
Proteinuria
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Rash pustular
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
6.1%
2/33 • Number of events 3 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Stomach pain
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Toothache
|
12.1%
4/33 • Number of events 4 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
21.2%
7/33 • Number of events 7 • Up to 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
42.4%
14/33 • Number of events 19 • Up to 5 years
|
|
Investigations
Weight loss
|
12.1%
4/33 • Number of events 4 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.1%
4/33 • Number of events 4 • Up to 5 years
|
|
Investigations
White blood cell decreased
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Tooth Infection
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
6.1%
2/33 • Number of events 4 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Reproductive system and breast disorders - Other
|
3.0%
1/33 • Number of events 3 • Up to 5 years
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Presyncope
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Neuralgia
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
3.0%
1/33 • Number of events 2 • Up to 5 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Hot flashes
|
3.0%
1/33 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.0%
1/33 • Number of events 2 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
General disorders
Flu like symptoms
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
General disorders
Fever
|
9.1%
3/33 • Number of events 3 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Eye disorders
Eye pain
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
6.1%
2/33 • Number of events 2 • Up to 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
|
Immune system disorders
Allergic reaction
|
3.0%
1/33 • Number of events 1 • Up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place