Trial Outcomes & Findings for A Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer (NCT NCT02694718)

Last Updated: 2017-01-11

Results Overview

Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Up to Week 16

Results posted on

2017-01-11

Participant Flow

A total of 60 participants were enrolled in this study conducted from 30 March 2005 to 28 November 2006 at 6 centers in Switzerland.

Participant milestones

Participant milestones
Measure	Capecitabine + Oxaliplatin Eligible participants received capecitabine 1000 milligrams per square meter (mg/m\^2) on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Overall Study STARTED	60
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Capecitabine + Oxaliplatin Eligible participants received capecitabine 1000 milligrams per square meter (mg/m\^2) on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Overall Study Death	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capecitabine + Oxaliplatin n=60 Participants Eligible participants received capecitabine 1000 mg/m\^2 on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Age, Continuous	61 years n=99 Participants
Gender Female	14 Participants n=99 Participants
Gender Male	46 Participants n=99 Participants

PRIMARY outcome

Timeframe: Up to Week 16

Population: The intent to treat (ITT) population included all participants, who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Capecitabine + Oxaliplatin n=60 Participants Eligible participants received capecitabine 1000 mg/m\^2 on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Percentage of Participants With Pathological Complete Tumor Response	23 Percentage of participants Interval 13.4 to 36.0

SECONDARY outcome

Timeframe: Up to Week 16

Population: ITT population included all participants, who received at least one dose of study drug. Two participants from the ITT population did not undergo surgery (one died, one withdrew consent).

Percentage of participants with sphincter-preservation is reported.

Outcome measures

Outcome measures
Measure	Capecitabine + Oxaliplatin n=58 Participants Eligible participants received capecitabine 1000 mg/m\^2 on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Percentage of Participants With Sphincter-preservation	84.48 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 16

Population: Safety population included all the participants who received at least one dose of any of the study treatments and who had a baseline assessment.

Number of participants with marked laboratory abnormalities is reported.

Outcome measures

Outcome measures
Measure	Capecitabine + Oxaliplatin n=60 Participants Eligible participants received capecitabine 1000 mg/m\^2 on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Number of Participants With Marked Laboratory Abnormalities Hemoglobin	7 Participants
Number of Participants With Marked Laboratory Abnormalities Hematocrit	7 Participants
Number of Participants With Marked Laboratory Abnormalities Erythrocytes	16 Participants
Number of Participants With Marked Laboratory Abnormalities Leucocytes total	8 Participants
Number of Participants With Marked Laboratory Abnormalities Neutrophils	9 Participants
Number of Participants With Marked Laboratory Abnormalities Basophils	1 Participants
Number of Participants With Marked Laboratory Abnormalities Eosinophils	2 Participants
Number of Participants With Marked Laboratory Abnormalities Monocytes	2 Participants
Number of Participants With Marked Laboratory Abnormalities Lymphocytes	42 Participants
Number of Participants With Marked Laboratory Abnormalities Platelets	13 Participants
Number of Participants With Marked Laboratory Abnormalities ASAT/SGOT	2 Participants
Number of Participants With Marked Laboratory Abnormalities ALAT/SGPT	10 Participants
Number of Participants With Marked Laboratory Abnormalities Serum albumin	3 Participants
Number of Participants With Marked Laboratory Abnormalities Total protein	2 Participants
Number of Participants With Marked Laboratory Abnormalities Serum creatinine	2 Participants
Number of Participants With Marked Laboratory Abnormalities Glucose	13 Participants
Number of Participants With Marked Laboratory Abnormalities Sodium	2 Participants
Number of Participants With Marked Laboratory Abnormalities Potassium	2 Participants
Number of Participants With Marked Laboratory Abnormalities Calcium	2 Participants

SECONDARY outcome

Timeframe: Up to Week 16

Population: The ITT consists of all included participants, who received at least one dose of study drug. Five participants from ITT population with T4 rectal cancer underwent surgery.

R0 resection was defined as complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation as confirmed by pathology after pre-operative chemotherapy plus capecitabine + oxaliplatin therapy.

Outcome measures

Outcome measures
Measure	Capecitabine + Oxaliplatin n=5 Participants Eligible participants received capecitabine 1000 mg/m\^2 on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer	100 Percentage of participants

SECONDARY outcome

Timeframe: From screening to Week 16

Population: ITT population included all participants, who received at least one dose of study drug.

Downstaging of primary tumor (T) and/or lymph nodes (N) was defined as decrease by 1 point in T-value and/or N-value (comparing at screening and after treatment). It was assessed by colonoscopy, pathology, endosonography of rectum, chest X-ray, abdominopelvic Computed Tomography and Magnetic Resonance Imaging. Staging for tumor are: TX (primary tumor cannot be assessed), T0 (no evidence of primary tumor), Tis (carcinoma in situ), T1 (tumor invades submucosa), T2 (tumor invades muscularis propria), T3 (tumor invades through muscularis propria into subserosa/into non-peritonealized pericolic/perirectal tissues, T4 (tumor directly invades other organs or structures). Staging for lymph nodes are: NX (regional lymph nodes cannot be assessed), N0 (no regional lymph node metastasis), N1 (metastasis in 1 to 3 regional lymph nodes), N2 (metastasis in 4 or more regional lymph nodes).

Outcome measures

Outcome measures
Measure	Capecitabine + Oxaliplatin n=60 Participants Eligible participants received capecitabine 1000 mg/m\^2 on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes T stage	47 Percentage of participants
Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes N stage	48 Percentage of participants
Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes Overall	65 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 16

Population: ITT population included all participants, who received at least one dose of study medication.

Pathological incomplete tumor response was defined as grade 1 or 2 in the histological grading of regression according to Dworak grading of regression. Pathological incomplete tumor response rate, Grade 1: dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2: dominantly fibrotic changes with few tumor cells or groups (easy to find) were assessed.

Outcome measures

Outcome measures
Measure	Capecitabine + Oxaliplatin n=60 Participants Eligible participants received capecitabine 1000 mg/m\^2 on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Percentage of Participants With Pathological Incomplete Tumor Response	72 Percentage of participants Interval 58.6 to 82.5

SECONDARY outcome

Timeframe: Up to Week 16

Population: Safety population included all the participants who received at least one dose of any of the study treatments and who had a baseline assessment.

An adverse event (AE) is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Capecitabine + Oxaliplatin n=60 Participants Eligible participants received capecitabine 1000 mg/m\^2 on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Number of Participants With Any Adverse Events and Serious Adverse Events Any AEs	59 Participants
Number of Participants With Any Adverse Events and Serious Adverse Events Any SAEs	8 Participants

Adverse Events

Capecitabine + Oxaliplatin

Serious events: 8 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Capecitabine + Oxaliplatin n=60 participants at risk Eligible participants received capecitabine 1000 mg/m\^2 on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Gastrointestinal disorders Diarrhoea	8.3% 5/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Gastrointestinal disorders Abdominal Pain	1.7% 1/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Gastrointestinal disorders Anal Haemorrhage	1.7% 1/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Gastrointestinal disorders Colitis	1.7% 1/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Gastrointestinal disorders Proctitis	1.7% 1/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Gastrointestinal disorders Stomatitis	1.7% 1/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Gastrointestinal disorders Subileus	1.7% 1/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Infections and infestations Sepsis	1.7% 1/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.

Other adverse events

Other adverse events
Measure	Capecitabine + Oxaliplatin n=60 participants at risk Eligible participants received capecitabine 1000 mg/m\^2 on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Gastrointestinal disorders Diarrhoea	70.0% 42/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Gastrointestinal disorders Nausea	33.3% 20/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Gastrointestinal disorders Proctitis	23.3% 14/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Gastrointestinal disorders Abdominal Pain	13.3% 8/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Gastrointestinal disorders Vomiting	13.3% 8/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Gastrointestinal disorders Painful Defaecation	11.7% 7/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Gastrointestinal disorders Proctalgia	11.7% 7/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Gastrointestinal disorders Constipation	10.0% 6/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
General disorders Fatigue	45.0% 27/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
General disorders Temperature Intorlerance	6.7% 4/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
General disorders Pain	5.0% 3/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Investigations Weight Decrease	8.3% 5/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Metabolism and nutrition disorders Anorexia	18.3% 11/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Nervous system disorders Neuropathy	21.7% 13/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Nervous system disorders Paraesthesia	16.7% 10/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Nervous system disorders Dysgeusia	8.3% 5/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Nervous system disorders Peripheral Sensory Neropathy	8.3% 5/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Nervous system disorders Neuropathy Peripheral	6.7% 4/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Renal and urinary disorders Pollakiuria	20.0% 12/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Renal and urinary disorders Dysuria	8.3% 5/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Renal and urinary disorders Nocturia	5.0% 3/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.3% 5/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Skin and subcutaneous tissue disorders Hand and Foot Syndrome	10.0% 6/60 • Up to Week 16 AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 61 6878333

Email: [email protected]

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