Trial Outcomes & Findings for A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer (NCT NCT01130337)
NCT ID: NCT01130337
Last Updated: 2015-10-01
Results Overview
DFS was the time elapsed from the time of surgery (for complete resection \[R0\] participants) until the date on which progression or death from any cause was documented (whichever occured first). Progression was defined as target lesions greater than (\>) 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 millimeter (mm) increase over the nadir. When the sum becomes very small, increases within the measurement error (2-3 mm) can lead to a 20% increase. Participants who did not present progression and who had not died were censored on the last date on which it was known that there was no progression (last response assessment).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Month 18
Results posted on
2015-10-01
Participant Flow
Screening period comprised of 35 days. A total of 136 participants were included in the study, of which 36 participants were enrolled and 100 participants discontinued due to screening failures. Abbreviation of AE= adverse event.
Participant milestones
| Measure |
Capecitabine+Oxaliplatin+Trastuzumab
Participants received 3 cycles of capecitabine (1,000 milligrams per meter squared \[mg/m\^2\] tablet orally \[p.o\] twice daily, Days 1-14)/oxaliplatin (130 mg/m\^2 as a 120-minute intravenous \[IV\] infusion, Day 1 of the cycle)/trastuzumab (8 milligrams per kilograms \[mg/kg\] on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Capecitabine+Oxaliplatin+Trastuzumab
Participants received 3 cycles of capecitabine (1,000 milligrams per meter squared \[mg/m\^2\] tablet orally \[p.o\] twice daily, Days 1-14)/oxaliplatin (130 mg/m\^2 as a 120-minute intravenous \[IV\] infusion, Day 1 of the cycle)/trastuzumab (8 milligrams per kilograms \[mg/kg\] on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Principal investigator decision
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Disease progression
|
1
|
|
Overall Study
Toxicity, AE/intercurrent disease
|
7
|
|
Overall Study
Surgical resection (R2)
|
1
|
Baseline Characteristics
A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer
Baseline characteristics by cohort
| Measure |
Capecitabine+Oxaliplatin+Trastuzumab
n=36 Participants
Participants received 3 cycles of capecitabine (1,000 mg/m\^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m\^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
|
|---|---|
|
Age, Continuous
|
63.44 years
STANDARD_DEVIATION 10.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 18Population: ITT population.
DFS was the time elapsed from the time of surgery (for complete resection \[R0\] participants) until the date on which progression or death from any cause was documented (whichever occured first). Progression was defined as target lesions greater than (\>) 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 millimeter (mm) increase over the nadir. When the sum becomes very small, increases within the measurement error (2-3 mm) can lead to a 20% increase. Participants who did not present progression and who had not died were censored on the last date on which it was known that there was no progression (last response assessment).
Outcome measures
| Measure |
Capecitabine+Oxaliplatin+Trastuzumab
n=36 Participants
Participants received 3 cycles of capecitabine (1,000 mg/m\^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m\^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
|
|---|---|
|
Percentage of Participants With Disease-free Survival (DFS) at Month 18
|
76.12 percentage of participants
Interval 57.72 to 87.32
|
SECONDARY outcome
Timeframe: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25Population: ITT population.
pCR was defined as an absence of any invasive cancer cell of the primary tumor after the time of major neoadjuvant chemotherapy, with or without surgery.
Outcome measures
| Measure |
Capecitabine+Oxaliplatin+Trastuzumab
n=36 Participants
Participants received 3 cycles of capecitabine (1,000 mg/m\^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m\^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
|
|---|---|
|
Percentage of Participants With Pathological Complete Response (pCR)
|
8.33 percentage of participants
Interval 1.75 to 22.47
|
SECONDARY outcome
Timeframe: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25Population: ITT population. Here "number of participants analyzed" included those who underwent surgery.
R0 resection was defined as having performed a complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation.
Outcome measures
| Measure |
Capecitabine+Oxaliplatin+Trastuzumab
n=31 Participants
Participants received 3 cycles of capecitabine (1,000 mg/m\^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m\^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
|
|---|---|
|
Percentage of Participants With Complete Tumor Resection (R0)
|
90.32 percentage of participants
Interval 74.25 to 97.96
|
SECONDARY outcome
Timeframe: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25Population: ITT population.
An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR was defined as the disappearance of all target lesions and persistence of greater than or equal to (≥) 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Capecitabine+Oxaliplatin+Trastuzumab
n=36 Participants
Participants received 3 cycles of capecitabine (1,000 mg/m\^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m\^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
|
|---|---|
|
Percentage of Participants With Objective Response
|
38.89 percentage of participants
|
Adverse Events
Capecitabine+Oxaliplatin+Trastuzumab
Serious events: 22 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Capecitabine+Oxaliplatin+Trastuzumab
n=36 participants at risk
Participants received 3 cycles of capecitabine (1,000 mg/m\^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m\^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
|
|---|---|
|
Cardiac disorders
Cardiogenic shock
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.9%
5/36 • Number of events 6 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Dysphagia
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Localised intra-abdominal fluid collection
|
5.6%
2/36 • Number of events 2 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
General disorders
Mucosal inflammation
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
General disorders
Multi-organ failure
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
General disorders
Pyrexia
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
General disorders
Sudden death
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Infections and infestations
Abdominal sepsis
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Infections and infestations
Appendicitis
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Infections and infestations
Pneumonia
|
5.6%
2/36 • Number of events 2 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Infections and infestations
Postoperative wound infection
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Infections and infestations
Sepsis
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Infections and infestations
Septic shock
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Nervous system disorders
Encephalopathy
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Psychiatric disorders
Schizoaffective disorder
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Renal and urinary disorders
Renal failure acute
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.6%
2/36 • Number of events 2 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Vascular disorders
Hypovolaemic shock
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Vascular disorders
Peripheral ischaemia
|
2.8%
1/36 • Number of events 1 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
Other adverse events
| Measure |
Capecitabine+Oxaliplatin+Trastuzumab
n=36 participants at risk
Participants received 3 cycles of capecitabine (1,000 mg/m\^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m\^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
30.6%
11/36 • Number of events 13 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.4%
7/36 • Number of events 16 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
4/36 • Number of events 16 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
9/36 • Number of events 12 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.9%
5/36 • Number of events 8 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
6/36 • Number of events 6 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Diarrhoea
|
80.6%
29/36 • Number of events 68 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
3/36 • Number of events 3 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Dysphagia
|
13.9%
5/36 • Number of events 13 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
2/36 • Number of events 2 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Nausea
|
47.2%
17/36 • Number of events 29 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
15/36 • Number of events 26 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
General disorders
Asthenia
|
66.7%
24/36 • Number of events 61 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
General disorders
Mucosal inflammation
|
22.2%
8/36 • Number of events 9 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
General disorders
Pyrexia
|
27.8%
10/36 • Number of events 13 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
8.3%
3/36 • Number of events 3 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
3/36 • Number of events 5 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
2/36 • Number of events 4 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Investigations
Ejection fraction decreased
|
5.6%
2/36 • Number of events 2 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
41.7%
15/36 • Number of events 30 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
2/36 • Number of events 4 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
3/36 • Number of events 5 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.6%
2/36 • Number of events 2 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
2/36 • Number of events 2 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Nervous system disorders
Dysaesthesia
|
19.4%
7/36 • Number of events 18 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Nervous system disorders
Dysgeusia
|
8.3%
3/36 • Number of events 5 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
6/36 • Number of events 9 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Nervous system disorders
Neurotoxicity
|
27.8%
10/36 • Number of events 16 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
6/36 • Number of events 11 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
2/36 • Number of events 6 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Psychiatric disorders
Anxiety
|
5.6%
2/36 • Number of events 2 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
8.3%
3/36 • Number of events 7 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
3/36 • Number of events 4 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
3/36 • Number of events 13 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
3/36 • Number of events 3 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
2/36 • Number of events 2 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
8.3%
3/36 • Number of events 4 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.6%
2/36 • Number of events 4 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
2/36 • Number of events 2 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
2/36 • Number of events 2 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
|
Vascular disorders
Hypertension
|
5.6%
2/36 • Number of events 2 • Before Day 1 of each cycle until Month 25
The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER