Trial Outcomes & Findings for A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes? (NCT NCT02287025)
NCT ID: NCT02287025
Last Updated: 2017-10-19
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2017-10-19
Participant Flow
The study was conducted at 10 study centers in United States, from 11 NOV 2014 (first subject first visit) to 26 FEB 2016 (last subject last visit).
Of the 23 screen participants, 2 participants were screen fails, 2 consented but never started treatment due to early study termination and 19 patients entered treatment.
Unit of analysis: study sites
Participant milestones
| Measure |
SMART
Investigators were supported with enhanced drug-specific information via an iPad application (SMART).
|
Standard of Care
Investigators were supported with standard prescribing information.
|
|---|---|---|
|
Overall Study
STARTED
|
12 6
|
11 4
|
|
Overall Study
COMPLETED
|
2 6
|
2 4
|
|
Overall Study
NOT COMPLETED
|
10 0
|
9 0
|
Reasons for withdrawal
| Measure |
SMART
Investigators were supported with enhanced drug-specific information via an iPad application (SMART).
|
Standard of Care
Investigators were supported with standard prescribing information.
|
|---|---|---|
|
Overall Study
Not treated
|
2
|
0
|
|
Overall Study
Progression of disease
|
3
|
2
|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Screening failed
|
1
|
1
|
Baseline Characteristics
A Phase 4 Study of Regorafenib in Metastatic Colorectal Cancer - Does Educating Physicians Change Patient Outcomes?
Baseline characteristics by cohort
| Measure |
Total
n=23 Participants
Total of all reporting groups
|
SMART
n=12 Participants
Participants received 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off. Investigators were supported with enhanced drug-specific information via an iPad application (SMART).
|
Standard of Care
n=11 Participants
Participants received 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off. Investigators were supported with standard prescribing information.
|
|---|---|---|---|
|
Age, Continuous
|
60.52 Years
STANDARD_DEVIATION 11.70 • n=5 Participants
|
61.08 Years
STANDARD_DEVIATION 15.28 • n=5 Participants
|
59.91 Years
STANDARD_DEVIATION 4.29 • n=7 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: The study was pre-maturely terminated. No data were collected from participants for this assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: The study was pre-maturely terminated. No data were collected from participants for this assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: The study was pre-maturely terminated. No data were collected from participants for this assessment.
Dose level 0 (standard starting dose) @ 160mg po qd. Dose level - 1 @ 120 mg po qd. Dose level - 2 @ 80 mg po qd. This schedule reflects the FDA-approved dosing specified in the prescribing information.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: The study was pre-maturely terminated. No data were collected from participants for this assessment.
Documented during visits as part of the interval history. All AEs will be reported in the CRF with a diagnosis, start/stop dates, action taken.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: The study was pre-maturely terminated. No data were collected from participants for this assessment.
Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: The study was pre-maturely terminated. No data were collected from participants for this assessment.
Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale.
Outcome measures
Outcome data not reported
Adverse Events
Regorafenib (Stivarga, BAY 73-4506)
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regorafenib (Stivarga, BAY 73-4506)
n=19 participants at risk
Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
|
|---|---|
|
Cardiac disorders
HEART FAILURE
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
General disorders
FEVER
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Infections and infestations
PNEUMONIA
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Nervous system disorders
HEMORRHAGE BRAIN
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
Other adverse events
| Measure |
Regorafenib (Stivarga, BAY 73-4506)
n=19 participants at risk
Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
|
|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
10.5%
2/19 • Number of events 5 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Eye disorders
BLURRED VISION
|
5.3%
1/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Eye disorders
CONJUNCTIVITIS
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
31.6%
6/19 • Number of events 7 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
CONSTIPATION
|
36.8%
7/19 • Number of events 8 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
DIARRHEA
|
47.4%
9/19 • Number of events 21 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
DRY MOUTH
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
FLATULENCE
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
LIP SWELLING
|
5.3%
1/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
NAUSEA
|
36.8%
7/19 • Number of events 8 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
OROPHARYNGEAL CONDITIONS
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
PROCTITIS
|
5.3%
1/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
SORES MOUTH
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
STOOL DISCOLORED
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Gastrointestinal disorders
VOMITING
|
26.3%
5/19 • Number of events 6 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
General disorders
ASTHENIA
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
General disorders
CHEST PAIN
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
General disorders
CHILLS
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
General disorders
FATIGUE
|
63.2%
12/19 • Number of events 18 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
General disorders
FEVER
|
21.1%
4/19 • Number of events 5 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
General disorders
GAIT DISTURBANCE
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
General disorders
OEDEMA PERIPHERAL
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
General disorders
PAIN
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
General disorders
PERIPHERAL SWELLING
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
General disorders
RASH GENERALIZED
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
General disorders
SLIGHT FEVER
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
General disorders
SWELLING OF LEGS
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Hepatobiliary disorders
ALANINE AMINOTRANSFERASE INCREASED
|
15.8%
3/19 • Number of events 3 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Hepatobiliary disorders
ALKALINE PHOSPHATASE INCREASED
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Hepatobiliary disorders
ALT INCREASED
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Hepatobiliary disorders
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Hepatobiliary disorders
AST INCREASED
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Hepatobiliary disorders
BLOOD BILIRUBIN INCREASED
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Hepatobiliary disorders
HYPERBILIRUBINEMIA
|
10.5%
2/19 • Number of events 3 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Hepatobiliary disorders
LIVER FUNCTION TEST ABNORMAL
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Immune system disorders
ALLERGIC REACTION TO ANTIBIOTIC
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Injury, poisoning and procedural complications
DERMATITIS RADIATION
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
36.8%
7/19 • Number of events 8 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
15.8%
3/19 • Number of events 3 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Metabolism and nutrition disorders
WEIGHT LOSS
|
15.8%
3/19 • Number of events 3 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.5%
2/19 • Number of events 3 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
BILATERAL MUSCLE WEAKNESS LOWER LIMB
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
BUTTOCK PAIN
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
FOOT PAIN
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
LOW BACK PAIN
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASM
|
5.3%
1/19 • Number of events 3 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN BACK
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN HIP
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Musculoskeletal and connective tissue disorders
UNILATERAL LEG PAIN
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Nervous system disorders
DIZZINESS
|
15.8%
3/19 • Number of events 4 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Nervous system disorders
DYSGEUSIA
|
10.5%
2/19 • Number of events 3 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Nervous system disorders
HEADACHE
|
31.6%
6/19 • Number of events 7 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Nervous system disorders
LETHARGY
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Nervous system disorders
POSITIONAL LIGHTHEADEDNESS
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Psychiatric disorders
ANXIETY
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Psychiatric disorders
DEPRESSION
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Psychiatric disorders
HALLUCINATIONS
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Psychiatric disorders
INSOMNIA
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Renal and urinary disorders
DYSURIA
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Renal and urinary disorders
URINARY URGENCY
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Renal and urinary disorders
URINE DISCOLORATION
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
21.1%
4/19 • Number of events 4 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
HEMOPTYSIS
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
21.1%
4/19 • Number of events 4 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL INFLAMMATION
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
15.8%
3/19 • Number of events 4 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
15.8%
3/19 • Number of events 3 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
15.8%
3/19 • Number of events 3 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
FLUSHING
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
HAND AND FOOT REACTION
|
10.5%
2/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
HAND AND FOOT SYNDROME
|
26.3%
5/19 • Number of events 10 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
|
5.3%
1/19 • Number of events 2 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.5%
2/19 • Number of events 3 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Vascular disorders
HEMATOMA
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Vascular disorders
HYPERTENSION
|
15.8%
3/19 • Number of events 9 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
|
Vascular disorders
HYPOTENSION
|
5.3%
1/19 • Number of events 1 • All AEs occurring from the time the subject has signed ICF until 30 days after the last dose of study drug
SAF (N= 19) included all subjects who received at least one dose of the study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60