Trial Outcomes & Findings for TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (NCT NCT03686488)
NCT ID: NCT03686488
Last Updated: 2025-12-24
Results Overview
Overall survival defined as the time from starting on trial to date of death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
6 months
Results posted on
2025-12-24
Participant Flow
Participant milestones
| Measure |
TAS 102 and Ramucirumab
TAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.
TAS 102: TAS 102 35 mg will be administered orally twice daily every 2 weeks.
Ramucirumab 10 MG/ML Intravenous Solution \[CYRAMZA\]: Ramucirumab 8 milligrams/kilogram will be administered as a 60 minute intravenous (IV) infusion every 2 weeks.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Baseline characteristics by cohort
| Measure |
TAS 102 and Ramucirumab
n=23 Participants
TAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.
TAS 102: TAS 102 35 mg will be administered orally twice daily every 2 weeks.
Ramucirumab 10 MG/ML Intravenous Solution \[CYRAMZA\]: Ramucirumab 8 milligrams/kilogram will be administered as a 60 minute intravenous (IV) infusion every 2 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOverall survival defined as the time from starting on trial to date of death from any cause.
Outcome measures
| Measure |
TAS 102 and Ramucirumab
n=23 Participants
TAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.
TAS 102: TAS 102 35 mg will be administered orally twice daily every 2 weeks.
Ramucirumab 10 MG/ML Intravenous Solution \[CYRAMZA\]: Ramucirumab 8 milligrams/kilogram will be administered as a 60 minute intravenous (IV) infusion every 2 weeks.
|
|---|---|
|
Overall Survival
|
4.8 months
Interval 4.0 to
Upper limit was not reached
|
SECONDARY outcome
Timeframe: 4 weeks after end of study participation, an average of 6.5 monthsNumber of participants with at least one adverse event.
Outcome measures
| Measure |
TAS 102 and Ramucirumab
n=23 Participants
TAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.
TAS 102: TAS 102 35 mg will be administered orally twice daily every 2 weeks.
Ramucirumab 10 MG/ML Intravenous Solution \[CYRAMZA\]: Ramucirumab 8 milligrams/kilogram will be administered as a 60 minute intravenous (IV) infusion every 2 weeks.
|
|---|---|
|
Number of Participants With at Least One Adverse Event
|
23 participants
|
SECONDARY outcome
Timeframe: 6 monthsPFS, defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Outcome measures
| Measure |
TAS 102 and Ramucirumab
n=23 Participants
TAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.
TAS 102: TAS 102 35 mg will be administered orally twice daily every 2 weeks.
Ramucirumab 10 MG/ML Intravenous Solution \[CYRAMZA\]: Ramucirumab 8 milligrams/kilogram will be administered as a 60 minute intravenous (IV) infusion every 2 weeks.
|
|---|---|
|
Progression Free Survival (PFS)
|
4.9 months
Interval 4.0 to
Not Reached
|
SECONDARY outcome
Timeframe: up to 12 monthsPopulation: Evaluable participants
Objective Response Rate is defined as complete response (CR) + partial response (PR) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Complete Response is 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. Partial Response is 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 |
TAS 102 and Ramucirumab
n=18 Participants
TAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.
TAS 102: TAS 102 35 mg will be administered orally twice daily every 2 weeks.
Ramucirumab 10 MG/ML Intravenous Solution \[CYRAMZA\]: Ramucirumab 8 milligrams/kilogram will be administered as a 60 minute intravenous (IV) infusion every 2 weeks.
|
|---|---|
|
Objective Response Rate
|
11 percentage of participants
Interval 9.622 to 12.578
|
Adverse Events
TAS 102 and Ramucirumab
Serious events: 7 serious events
Other events: 23 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
TAS 102 and Ramucirumab
n=23 participants at risk
TAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.
TAS 102: TAS 102 35 mg will be administered orally twice daily every 2 weeks.
Ramucirumab 10 MG/ML Intravenous Solution \[CYRAMZA\]: Ramucirumab 8 milligrams/kilogram will be administered as a 60 minute intravenous (IV) infusion every 2 weeks.
|
|---|---|
|
General disorders
Death NOS
|
13.0%
3/23 • Number of events 3 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
General disorders
Sudden death NOS
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
General disorders
Multi-organ failure
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
General disorders
Flu like symptoms
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Infections and infestations
Infections and infestations- Other
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
1/23 • Number of events 3 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Vascular disorders
Stroke
|
4.3%
1/23 • Number of events 3 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
Other adverse events
| Measure |
TAS 102 and Ramucirumab
n=23 participants at risk
TAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.
TAS 102: TAS 102 35 mg will be administered orally twice daily every 2 weeks.
Ramucirumab 10 MG/ML Intravenous Solution \[CYRAMZA\]: Ramucirumab 8 milligrams/kilogram will be administered as a 60 minute intravenous (IV) infusion every 2 weeks.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
26.1%
6/23 • Number of events 6 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders -Other
|
21.7%
5/23 • Number of events 6 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.4%
4/23 • Number of events 9 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Toothache
|
13.0%
3/23 • Number of events 3 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Ascites
|
8.7%
2/23 • Number of events 2 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Dysphagia
|
8.7%
2/23 • Number of events 2 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Dental caries
|
4.3%
1/23 • Number of events 2 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Stomach pain
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
General disorders
Fatigue
|
60.9%
14/23 • Number of events 16 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
General disorders
General disorders and administration site conditions - Other
|
21.7%
5/23 • Number of events 7 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
General disorders
Chills
|
17.4%
4/23 • Number of events 5 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
General disorders
Pain
|
17.4%
4/23 • Number of events 4 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
General disorders
Edema limbs
|
13.0%
3/23 • Number of events 3 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
General disorders
Non-cardiac chest pain
|
13.0%
3/23 • Number of events 5 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
General disorders
Flu like symptoms
|
8.7%
2/23 • Number of events 2 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
General disorders
Fever
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
General disorders
Multi-organ failure
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Nervous system disorders
Headache
|
47.8%
11/23 • Number of events 16 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Nervous system disorders
Dizziness
|
26.1%
6/23 • Number of events 6 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Nervous system disorders
Nervous system disorders - Other
|
8.7%
2/23 • Number of events 2 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Nervous system disorders
Stroke
|
4.3%
1/23 • Number of events 2 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Investigations
Neutrophil count decreased
|
26.1%
6/23 • Number of events 11 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Investigations
White blood cell decreased
|
17.4%
4/23 • Number of events 5 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Investigations
Lymphocyte count decreased
|
13.0%
3/23 • Number of events 3 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Investigations
Platelet count decreased
|
8.7%
2/23 • Number of events 4 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Investigations
Weight gain
|
8.7%
2/23 • Number of events 3 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Investigations
Weight loss
|
8.7%
2/23 • Number of events 2 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Investigations
Blood bilirubin increased
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Investigations
Lipase increased
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Vascular disorders
Hypertension
|
39.1%
9/23 • Number of events 9 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Vascular disorders
Hypotension
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Vascular disorders
Thromboembolic event
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
26.1%
6/23 • Number of events 7 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.7%
2/23 • Number of events 2 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.1%
6/23 • Number of events 7 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.4%
4/23 • Number of events 6 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.0%
3/23 • Number of events 3 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
8.7%
2/23 • Number of events 2 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Vomiting
|
52.2%
12/23 • Number of events 15 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Diarrhea
|
56.5%
13/23 • Number of events 15 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Gastrointestinal disorders
Nausea
|
56.5%
13/23 • Number of events 15 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Blood and lymphatic system disorders
Anemia
|
21.7%
5/23 • Number of events 9 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
13.0%
3/23 • Number of events 3 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Infections and infestations
Bronchial infection
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Infections and infestations
Infections and infestations - Other
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Infections and infestations
Shingles
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Infections and infestations
Skin infection
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
13.0%
3/23 • Number of events 4 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Injury, poisoning and procedural complications
Fall
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Cardiac disorders
Palpitations
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Cardiac disorders
Pericardial effusion
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Psychiatric disorders
Anxiety
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Psychiatric disorders
Restlessness
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Renal and urinary disorders
Hematuria
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Renal and urinary disorders
Proteinuria
|
4.3%
1/23 • Number of events 2 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Renal and urinary disorders
Renal colic
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Renal and urinary disorders
Urinary frequency
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Renal and urinary disorders
Urine discoloration
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
4.3%
1/23 • Number of events 3 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Eye disorders
Blurred vision
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other,
|
4.3%
1/23 • Number of events 1 • Adverse events collected from first on treatment date to 4 weeks after end of treatment, an average of 6.5 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place