Trial Outcomes & Findings for A Phase III Study of NK105 in Patients With Breast Cancer (NCT NCT01644890)
NCT ID: NCT01644890
Last Updated: 2019-07-29
Results Overview
PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1. Assessment period was from the day of randomisation until the first observation of lesion progression or death
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
436 participants
Primary outcome timeframe
Baseline, every 6 weeks of study treatment period, and end of study,
Results posted on
2019-07-29
Participant Flow
This study was conducted from September 2012 to January 2016 in three asian countries (Japan, Korea, Taiwan).
Participant milestones
| Measure |
NK105
received NK105 (65 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
Paclitaxel
received Paclitaxel (80 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
|---|---|---|
|
Overall Study
STARTED
|
218
|
218
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
216
|
215
|
Reasons for withdrawal
| Measure |
NK105
received NK105 (65 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
Paclitaxel
received Paclitaxel (80 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
20
|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Physician Decision
|
3
|
9
|
|
Overall Study
Protocol Violation
|
6
|
7
|
|
Overall Study
Withdrawal by Subject
|
19
|
27
|
|
Overall Study
Progression Disease
|
160
|
131
|
|
Overall Study
Clinical Progression
|
6
|
6
|
|
Overall Study
> 28 days since last dose of study drug
|
6
|
3
|
|
Overall Study
Other
|
8
|
9
|
Baseline Characteristics
A Phase III Study of NK105 in Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
NK105
n=214 Participants
received NK105 (65 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
Paclitaxel
n=213 Participants
received Paclitaxel (80 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
Total
n=427 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
214 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
427 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
136 participants
n=5 Participants
|
143 participants
n=7 Participants
|
279 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
51 participants
n=5 Participants
|
42 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, every 6 weeks of study treatment period, and end of study,Population: All randomized patients who received study drug at least once and who had no major violations of the eligiblity criteria
PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1. Assessment period was from the day of randomisation until the first observation of lesion progression or death
Outcome measures
| Measure |
NK105
n=211 Participants
received NK105 (65 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
Paclitaxel
n=211 Participants
received Paclitaxel (80 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
|---|---|---|
|
Progression Free Survival
|
8.4 months
Interval 7.0 to 9.9
|
8.5 months
Interval 6.9 to 11.5
|
SECONDARY outcome
Timeframe: Baseline, every 6 weeks of study treatment period, and end of study.Population: History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status \[ER (+) or ER (-)\], and Disease free interval (\<12 months or ≥12 months) were covariates for adjustment.
OS is defined as the period from the day of randomization until the day of death from any cause. Assessment period was from the day of randomisation until the first observation of lesion progression or death
Outcome measures
| Measure |
NK105
n=211 Participants
received NK105 (65 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
Paclitaxel
n=211 Participants
received Paclitaxel (80 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
|---|---|---|
|
Overall Survival
|
31.2 months
Interval 27.1 to 39.3
|
36.2 months
Interval 30.3 to
NA = The upper limit of the Confidence Interval was not estimable as there were not enough events.
|
SECONDARY outcome
Timeframe: Baseline, every 6 weeks of study treatment period, and end of study.Population: All randomized patients who received study drug at least once and who had no major violations of the eligiblity criteria
ORR is the proportion of patients who are assessed as complete response or partial response as the best overall response among evaluable patients, according to RECIST Ver.1.1. Assessment period was from the day of randomisation until the first observation of lesion progression or death
Outcome measures
| Measure |
NK105
n=211 Participants
received NK105 (65 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
Paclitaxel
n=211 Participants
received Paclitaxel (80 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
|---|---|---|
|
Overall Response Rate
|
31.6 percentage of participants
Interval 25.0 to 38.7
|
39.0 percentage of participants
Interval 32.0 to 46.4
|
Adverse Events
NK105
Serious events: 34 serious events
Other events: 210 other events
Deaths: 3 deaths
Paclitaxel
Serious events: 27 serious events
Other events: 211 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
NK105
n=214 participants at risk
received NK105 (65 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
Paclitaxel
n=211 participants at risk；n=213 participants at risk
received Paclitaxel (80 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Cardiac disorders
Pericardial effusion
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Eye disorders
Cataract
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Constipation
|
0.93%
2/214 • Number of events 2 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.93%
2/214 • Number of events 2 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Ileus
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
3/214 • Number of events 3 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Oesophageal motility disorder
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Stomatitis
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
2/214 • Number of events 4 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
Asthenia
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
Chills
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
Death
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
Fatigue
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
General physical health deterioration
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
Infusion site extravasation
|
0.93%
2/214 • Number of events 2 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
Pyrexia
|
1.4%
3/214 • Number of events 4 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
Sudden death
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Hepatobiliary disorders
Cholestasis
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Immune system disorders
Anaphylactic reaction
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Infections and infestations
Device related infection
|
0.93%
2/214 • Number of events 2 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Infections and infestations
Pneumonia
|
0.93%
2/214 • Number of events 2 • The duration of treatment, mean duration was 294.7 days.
|
0.94%
2/213 • Number of events 2 • The duration of treatment, mean duration was 294.7 days.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 2 • The duration of treatment, mean duration was 294.7 days.
|
|
Infections and infestations
Sepsis
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Infections and infestations
Urinary tract infection
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.94%
2/213 • Number of events 2 • The duration of treatment, mean duration was 294.7 days.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Product Issues
Device dislocation
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Psychiatric disorders
Anxiety
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Psychiatric disorders
Depression
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.93%
2/214 • Number of events 2 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.93%
2/214 • Number of events 2 • The duration of treatment, mean duration was 294.7 days.
|
0.94%
2/213 • Number of events 2 • The duration of treatment, mean duration was 294.7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.47%
1/214 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
0.00%
0/213 • The duration of treatment, mean duration was 294.7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.93%
2/214 • Number of events 3 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/214 • The duration of treatment, mean duration was 294.7 days.
|
0.47%
1/213 • Number of events 1 • The duration of treatment, mean duration was 294.7 days.
|
Other adverse events
| Measure |
NK105
n=214 participants at risk
received NK105 (65 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
Paclitaxel
n=211 participants at risk；n=213 participants at risk
received Paclitaxel (80 mg/m\^2) on days 1, 8 and 15 of a 28-day cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.7%
23/214 • The duration of treatment, mean duration was 294.7 days.
|
10.4%
22/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.1%
11/214 • The duration of treatment, mean duration was 294.7 days.
|
7.1%
15/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Constipation
|
17.3%
37/214 • The duration of treatment, mean duration was 294.7 days.
|
19.9%
42/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.0%
47/214 • The duration of treatment, mean duration was 294.7 days.
|
19.4%
41/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Nausea
|
27.6%
59/214 • The duration of treatment, mean duration was 294.7 days.
|
30.8%
65/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Stomatitis
|
19.6%
42/214 • The duration of treatment, mean duration was 294.7 days.
|
21.8%
46/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Gastrointestinal disorders
Vomiting
|
14.5%
31/214 • The duration of treatment, mean duration was 294.7 days.
|
11.8%
25/211 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
Fatigue
|
21.0%
45/214 • The duration of treatment, mean duration was 294.7 days.
|
17.1%
36/211 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
Influenza like illness
|
2.3%
5/214 • The duration of treatment, mean duration was 294.7 days.
|
5.7%
12/211 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
Malaise
|
9.8%
21/214 • The duration of treatment, mean duration was 294.7 days.
|
17.5%
37/211 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
Oedema
|
2.8%
6/214 • The duration of treatment, mean duration was 294.7 days.
|
10.9%
23/211 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
Oedema peripheral
|
7.0%
15/214 • The duration of treatment, mean duration was 294.7 days.
|
19.4%
41/211 • The duration of treatment, mean duration was 294.7 days.
|
|
General disorders
Pyrexia
|
10.3%
22/214 • The duration of treatment, mean duration was 294.7 days.
|
12.8%
27/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Infections and infestations
Cystitis
|
5.1%
11/214 • The duration of treatment, mean duration was 294.7 days.
|
6.2%
13/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Infections and infestations
Nasopharyngitis
|
22.9%
49/214 • The duration of treatment, mean duration was 294.7 days.
|
21.8%
46/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Infections and infestations
Paronychia
|
3.3%
7/214 • The duration of treatment, mean duration was 294.7 days.
|
7.6%
16/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.1%
26/214 • The duration of treatment, mean duration was 294.7 days.
|
11.8%
25/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Investigations
Alanine aminotransferase increased
|
11.2%
24/214 • The duration of treatment, mean duration was 294.7 days.
|
10.4%
22/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Investigations
Aspartate aminotransferase increased
|
9.3%
20/214 • The duration of treatment, mean duration was 294.7 days.
|
7.1%
15/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.3%
20/214 • The duration of treatment, mean duration was 294.7 days.
|
6.6%
14/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Investigations
Lymphocyte count decreased
|
9.3%
20/214 • The duration of treatment, mean duration was 294.7 days.
|
11.8%
25/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Investigations
Neutrophil count decreased
|
50.9%
109/214 • The duration of treatment, mean duration was 294.7 days.
|
48.8%
103/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Investigations
Weight decreased
|
13.6%
29/214 • The duration of treatment, mean duration was 294.7 days.
|
17.1%
36/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Investigations
Weight increased
|
10.3%
22/214 • The duration of treatment, mean duration was 294.7 days.
|
12.3%
26/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Investigations
White blood cell count decreased
|
33.6%
72/214 • The duration of treatment, mean duration was 294.7 days.
|
32.2%
68/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.6%
27/214 • The duration of treatment, mean duration was 294.7 days.
|
18.5%
39/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.1%
28/214 • The duration of treatment, mean duration was 294.7 days.
|
18.0%
38/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
17/214 • The duration of treatment, mean duration was 294.7 days.
|
5.7%
12/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
32/214 • The duration of treatment, mean duration was 294.7 days.
|
21.8%
46/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Nervous system disorders
Dizziness
|
5.6%
12/214 • The duration of treatment, mean duration was 294.7 days.
|
9.5%
20/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Nervous system disorders
Dysgeusia
|
14.0%
30/214 • The duration of treatment, mean duration was 294.7 days.
|
25.1%
53/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Nervous system disorders
Headache
|
13.6%
29/214 • The duration of treatment, mean duration was 294.7 days.
|
17.1%
36/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
52.8%
113/214 • The duration of treatment, mean duration was 294.7 days.
|
70.6%
149/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Psychiatric disorders
Insomnia
|
7.5%
16/214 • The duration of treatment, mean duration was 294.7 days.
|
10.4%
22/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.3%
37/214 • The duration of treatment, mean duration was 294.7 days.
|
12.8%
27/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
12/214 • The duration of treatment, mean duration was 294.7 days.
|
3.8%
8/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.8%
21/214 • The duration of treatment, mean duration was 294.7 days.
|
6.6%
14/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.1%
13/214 • The duration of treatment, mean duration was 294.7 days.
|
5.2%
11/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
70.6%
151/214 • The duration of treatment, mean duration was 294.7 days.
|
76.3%
161/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
17.3%
37/214 • The duration of treatment, mean duration was 294.7 days.
|
21.8%
46/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.6%
27/214 • The duration of treatment, mean duration was 294.7 days.
|
9.5%
20/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
29.0%
62/214 • The duration of treatment, mean duration was 294.7 days.
|
22.3%
47/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.9%
17/214 • The duration of treatment, mean duration was 294.7 days.
|
5.7%
12/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.1%
11/214 • The duration of treatment, mean duration was 294.7 days.
|
2.4%
5/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
1.9%
4/214 • The duration of treatment, mean duration was 294.7 days.
|
7.1%
15/211 • The duration of treatment, mean duration was 294.7 days.
|
|
Vascular disorders
Hot flush
|
1.9%
4/214 • The duration of treatment, mean duration was 294.7 days.
|
5.7%
12/211 • The duration of treatment, mean duration was 294.7 days.
|
Additional Information
Pharmaceuticals Group
Nippon Kayaku Co., Ltd.
Phone: +81-3-6731-5200
Results disclosure agreements
- Principal investigator is a sponsor employee There is no day limit but it needs sponsor's consent in a document.
- Publication restrictions are in place
Restriction type: OTHER