Trial Outcomes & Findings for Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo-Controlled Phase-III STudy (NCT NCT01939223)
NCT ID: NCT01939223
Last Updated: 2017-10-20
Results Overview
Disease free survival was evaluated by CT / MRI scans as assessed by the investigator, which was defined as the time (in days) from date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. For subjects without documented disease recurrence or death at the time of analysis, the DFS time was censored at the date of the last evaluable CT / MRI scan.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
25 participants
Primary outcome timeframe
From date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented.
Results posted on
2017-10-20
Participant Flow
This multinational study was conducted at 32 study centers that screened 65 subjects across 9 countries, between 02 December 2013 (start of enrollment) and 29 August 2016 (last patient last vist).
Overall, 65 subjects were screened, of which 40 were screen failures. The remaining 25 subjects were randomized and assigned to treatment. All 25 subjects received treatment.
Participant milestones
| Measure |
Regorafenib 160 mg
Description: Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.
|
Placebo
Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
Participants Received Treatment
|
14
|
11
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
Reasons for withdrawal
| Measure |
Regorafenib 160 mg
Description: Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.
|
Placebo
Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
|
|---|---|---|
|
Overall Study
AE not assoc. with disease recurrence
|
1
|
1
|
|
Overall Study
Disease recurrence (radiological)
|
1
|
3
|
|
Overall Study
Study stopped by Sponsor
|
5
|
7
|
|
Overall Study
Withdrawal by Subject
|
6
|
0
|
Baseline Characteristics
Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo-Controlled Phase-III STudy
Baseline characteristics by cohort
| Measure |
Regorafenib 160 mg
n=14 Participants
Description: Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg tablets) orally once daily on a 3 weeks on / 1 week off dosing schedule.
|
Placebo
n=11 Participants
Subjects received placebo matching to regorafenib tablet orally once daily on a 3 weeks on / 1 week off dosing schedule.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 Years
STANDARD_DEVIATION 11.22 • n=5 Participants
|
57.0 Years
STANDARD_DEVIATION 9.83 • n=7 Participants
|
58.5 Years
STANDARD_DEVIATION 10.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented.Population: Number of Participants Analyzed is 0 because this study was prematurely terminated and data were not collected for this endpoint.
Disease free survival was evaluated by CT / MRI scans as assessed by the investigator, which was defined as the time (in days) from date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. For subjects without documented disease recurrence or death at the time of analysis, the DFS time was censored at the date of the last evaluable CT / MRI scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Subjects who experienced disease recurrence (either during treatment or during Active Follow-up), or otherwise withdrew from the study for any reason other than death, were followed for overall survival unless consent was withdrawn.Population: Number of Participants Analyzed is 0 because this study was prematurely terminated and data were not collected for this endpoint.
Overall survival (OS) is defined as the time (days) from randomization to death due to any cause. The OS time for subjects alive at the time of analysis was censored at their last date known to be alive.
Outcome measures
Outcome data not reported
Adverse Events
Regorafenib 160 mg (BAY73-4506)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regorafenib 160 mg (BAY73-4506)
n=14 participants at risk
Subjects received regorafenib 160 mg (4 \*40 mg tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC (best supportive care).
|
Placebo
n=11 participants at risk
Subjects received placebo matched to regorafenib tablets orally every day for 3 weeks followed by 1 week off treatment plus BSC (best supportive care).
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
Other adverse events
| Measure |
Regorafenib 160 mg (BAY73-4506)
n=14 participants at risk
Subjects received regorafenib 160 mg (4 \*40 mg tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC (best supportive care).
|
Placebo
n=11 participants at risk
Subjects received placebo matched to regorafenib tablets orally every day for 3 weeks followed by 1 week off treatment plus BSC (best supportive care).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Infections and infestations
Abscess oral
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
2/14 • Number of events 6 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Amylase increased
|
14.3%
2/14 • Number of events 4 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Gastrointestinal disorders
Anal fistula
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
18.2%
2/11 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
4/14 • Number of events 10 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
General disorders
Asthenia
|
28.6%
4/14 • Number of events 6 • From the start of study drug administration until 30 days after the last study medication intake.
|
18.2%
2/11 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
1/14 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Blood bilirubin increased
|
35.7%
5/14 • Number of events 7 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Blood bilirubin unconjugated increased
|
7.1%
1/14 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Blood lactate dehydrogenase increased
|
21.4%
3/14 • Number of events 3 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Gastrointestinal disorders
Cheilitis
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
General disorders
Chills
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
4/14 • Number of events 5 • From the start of study drug administration until 30 days after the last study medication intake.
|
18.2%
2/11 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
2/14 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Gastrointestinal disorders
Dental caries
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Infections and infestations
Device related infection
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
27.3%
3/11 • Number of events 5 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
35.7%
5/14 • Number of events 5 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Renal and urinary disorders
Dysuria
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Infections and infestations
Enterocolitis infectious
|
7.1%
1/14 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
7.1%
1/14 • Number of events 3 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
General disorders
Fatigue
|
14.3%
2/14 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
27.3%
3/11 • Number of events 3 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.1%
1/14 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
7.1%
1/14 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Gastrointestinal disorders
Gingival pain
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hair follicle tumour benign
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.1%
1/14 • Number of events 4 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Vascular disorders
Hypertension
|
50.0%
7/14 • Number of events 29 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Endocrine disorders
Hypothyroidism
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Infections and infestations
Laryngitis
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Lipase increased
|
28.6%
4/14 • Number of events 7 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 4 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Lymphocyte count decreased
|
7.1%
1/14 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
18.2%
2/11 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.3%
2/14 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.4%
3/14 • Number of events 4 • From the start of study drug administration until 30 days after the last study medication intake.
|
18.2%
2/11 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Neutrophil count decreased
|
14.3%
2/14 • Number of events 3 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Neutrophil count increased
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
General disorders
Oedema
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
42.9%
6/14 • Number of events 22 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
2/14 • Number of events 3 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Infections and infestations
Pharyngitis
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Platelet count decreased
|
28.6%
4/14 • Number of events 9 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Renal and urinary disorders
Proteinuria
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
General disorders
Pyrexia
|
21.4%
3/14 • Number of events 3 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
2/14 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis atrophic
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
2/14 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
18.2%
2/11 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
1/14 • Number of events 3 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • Number of events 4 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Weight decreased
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
Weight increased
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 2 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
White blood cell count decreased
|
21.4%
3/14 • Number of events 5 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
White blood cell count increased
|
7.1%
1/14 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
0.00%
0/11 • From the start of study drug administration until 30 days after the last study medication intake.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/14 • From the start of study drug administration until 30 days after the last study medication intake.
|
9.1%
1/11 • Number of events 1 • From the start of study drug administration until 30 days after the last study medication intake.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER