Trial Outcomes & Findings for Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer (NCT NCT00770874)
NCT ID: NCT00770874
Last Updated: 2019-06-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
375 participants
Primary outcome timeframe
From the date of randomization to death from any cause, assessed up to 296 events or the end of November 2015, whichever was earlier, each three months
Results posted on
2019-06-21
Participant Flow
375 patients were randomized to Arm A (189) or Arm B (186); of these, 364 patients(188 and 176, respectively) received study treatment. 11 patients (1 and 10, respectively) did not receive allocated intervention because of 'withdrew consent(1 and 6, respectively)' , 'ineligible criteria(3 in Arm B)', or 'investigator's discretion(1 in Arm B)'.
Participant milestones
| Measure |
S-1 + Cisplatin (Arm A)
S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
|
Cisplatin (Arm B)
Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
188
|
176
|
|
Overall Study
COMPLETED
|
188
|
176
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer
Baseline characteristics by cohort
| Measure |
S-1 + Cisplatin (Arm A)
n=188 Participants
S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
|
Cisplatin (Arm B)
n=174 Participants
Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
|
Total
n=362 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=99 Participants
|
52.5 years
n=107 Participants
|
54 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
188 Participants
n=99 Participants
|
174 Participants
n=107 Participants
|
362 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
South Korea
|
52 participants
n=99 Participants
|
49 participants
n=107 Participants
|
101 participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
110 participants
n=99 Participants
|
105 participants
n=107 Participants
|
215 participants
n=206 Participants
|
|
Region of Enrollment
Taiwan
|
26 participants
n=99 Participants
|
20 participants
n=107 Participants
|
46 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to death from any cause, assessed up to 296 events or the end of November 2015, whichever was earlier, each three monthsPopulation: Full analysis set
Outcome measures
| Measure |
S-1 + Cisplatin (Arm A)
n=188 Participants
S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
|
Cisplatin (Arm B)
n=174 Participants
Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
|
|---|---|---|
|
Overall Survival
|
21.9 months
Interval 18.6 to 25.8
|
19.5 months
Interval 17.0 to 24.3
|
SECONDARY outcome
Timeframe: About Progression free survival, from the randomization to disease progression or death, whichever came first, assessed up to until primary outcome came each three months, and about safety, from the first treatment to 30 days after the last treatmentPopulation: Full analysis set
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
S-1 + Cisplatin (Arm A)
n=188 Participants
S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
|
Cisplatin (Arm B)
n=174 Participants
Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
|
|---|---|---|
|
Progression Free Survival, Safety
|
7.3 months
Interval 6.7 to 8.1
|
4.9 months
Interval 4.4 to 5.7
|
Adverse Events
S-1 + Cisplatin (Arm A)
Serious events: 72 serious events
Other events: 188 other events
Deaths: 7 deaths
Cisplatin (Arm B)
Serious events: 34 serious events
Other events: 172 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
S-1 + Cisplatin (Arm A)
n=188 participants at risk
S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
|
Cisplatin (Arm B)
n=175 participants at risk
Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.1%
2/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.6%
3/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Ear and labyrinth disorders
Deafness
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Eye disorders
Glaucoma
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
3/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Ascities
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
9/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Illeus
|
1.1%
2/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Rectal stenosis
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.6%
3/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Stomatitis
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
4/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Subileus
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.1%
2/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
General disorders
Fatigue
|
1.6%
3/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
General disorders
Oedema peripheral
|
1.1%
2/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
General disorders
Pyrexia
|
2.1%
4/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
General disorders
Disease progression
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Gastroenteritis
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Herpes zoster
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Infectious colitis
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Infective myositis
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Peritonitis
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Salpingitis
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Sepsis
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Skin infection
|
1.1%
2/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
2/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
5/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
2.3%
4/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Ureteritis
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Uterine infection
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Device related infection
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Alanine aminotransferase increased
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Aspartate aminotransferase increased
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Blood albumin decreased
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Blood calcium decreased
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Blood glucose decreased
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Blood magnesium decreased
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Blood potassium decreased
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Blood sodium decreased
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Blood uric acid decreased
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Haemoglobin decreased
|
5.3%
10/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
2.9%
5/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Neutrophil count decreased
|
6.4%
12/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Platelet count decreased
|
2.7%
5/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
White blood cell count decreased
|
1.1%
2/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.1%
2/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
2/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Renal and urinary disorders
Hydroneprosis
|
1.1%
2/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Renal and urinary disorders
Renal failure
|
1.6%
3/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Renal and urinary disorders
Ureteric obstruction
|
2.7%
5/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Reproductive system and breast disorders
Breast engorgement
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.57%
1/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.53%
1/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
0.00%
0/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Vascular disorders
Thrombosis
|
5.3%
10/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
Other adverse events
| Measure |
S-1 + Cisplatin (Arm A)
n=188 participants at risk
S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks.
|
Cisplatin (Arm B)
n=175 participants at risk
Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.4%
12/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
2.9%
5/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
29/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
14.9%
26/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.8%
24/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
5.1%
9/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Constipation
|
32.4%
61/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
27.4%
48/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
94/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
29.1%
51/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Dyspesia
|
11.2%
21/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
6.9%
12/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Gastritis
|
10.1%
19/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
5.7%
10/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Nausea
|
81.4%
153/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
76.6%
134/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Stomatitis
|
31.4%
59/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
9.1%
16/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Vomiting
|
54.8%
103/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
40.6%
71/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Gastrointestinal disorders
Fatigue
|
58.0%
109/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
45.1%
79/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
General disorders
Influenza like illness
|
15.4%
29/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
9.7%
17/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
General disorders
Oedema peripheral
|
21.8%
41/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
9.1%
16/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
General disorders
Pyrexia
|
20.2%
38/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
11.4%
20/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
General disorders
Localised oedema
|
10.6%
20/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
8.6%
15/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Immune system disorders
Hypersensitivity
|
5.3%
10/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
5.1%
9/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Cystitis
|
6.4%
12/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
5.1%
9/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
12/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
3.4%
6/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Infections and infestations
Urinary tract infection
|
9.0%
17/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
6.9%
12/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Alanine aminotransferase increased
|
20.2%
38/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
13.1%
23/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Aspartate aminotransferase increased
|
17.6%
33/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
8.6%
15/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Blood albumin decreased
|
24.5%
46/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
13.1%
23/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Blood bilirubin decreased
|
11.2%
21/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.7%
3/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Blood calcium decreased
|
9.6%
18/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
3.4%
6/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Blood creatinine increased
|
20.2%
38/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
22.3%
39/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Blood potassium decreased
|
20.7%
39/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
5.1%
9/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Blood sodium decreased
|
16.0%
30/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
8.6%
15/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Haemoglobin decreased
|
78.2%
147/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
49.7%
87/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Lymphocyte count decreased
|
11.2%
21/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
5.7%
10/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Neutrophil count decreased
|
78.7%
148/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
37.1%
65/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Platelet count decreased
|
47.9%
90/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
14.9%
26/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Weight decreased
|
20.2%
38/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
5.7%
10/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Weight increased
|
5.9%
11/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
5.7%
10/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
White blood cell count decreased
|
48.9%
92/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
29.7%
52/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Investigations
Protein urine present
|
15.4%
29/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
7.4%
13/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
75.0%
141/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
60.0%
105/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.8%
26/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
6.9%
12/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.5%
16/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
5.1%
9/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
9/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
5.7%
10/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Nervous system disorders
Dizziness
|
19.7%
37/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
8.6%
15/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Nervous system disorders
Dysgeusia
|
18.1%
34/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
6.9%
12/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Nervous system disorders
Headache
|
17.0%
32/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
17.7%
31/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.7%
39/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
12.6%
22/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Psychiatric disorders
Insomnia
|
14.9%
28/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
12.0%
21/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Renal and urinary disorders
Ureteric obstruction
|
5.3%
10/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
2.9%
5/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.9%
11/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
2.9%
5/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.8%
24/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
6.9%
12/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.0%
15/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.2%
21/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
4.0%
7/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
25.5%
48/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
1.1%
2/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
19.1%
36/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
10.3%
18/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
|
Vascular disorders
Thrombosis
|
7.4%
14/188 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
2.3%
4/175 • From the date of the first treatment to 30 days after the last treatment
A total of 364 (188 in Arm A; 176 in Arm B) received study treatment. One patient in Arm B were excluded in the safety analysis, because of insufficient informed consent.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER