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A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer (JOSHUA)

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ClinicalTrials.gov Identifier: NCT01461057
Recruitment Status : Completed
First Posted : October 27, 2011
Results First Posted : June 27, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastric Cancer
Interventions Drug: Capecitabine
Drug: Cisplatin
Drug: Pertuzumab
Drug: Trastuzumab
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pertuzumab 840/420 mg Pertuzumab 840/840 mg
Hide Arm/Group Description Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles. Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles.
Period Title: Overall Study
Started 15 15
Completed 0 0
Not Completed 15 15
Reason Not Completed
Death             10             9
Withdrawal by Subject             2             3
Physician Decision             0             2
Adverse Event             0             1
Progression of Disease             1             0
Study Terminated by Sponsor             2             0
Arm/Group Title Pertuzumab 840/420 mg Pertuzumab 840/840 mg Total
Hide Arm/Group Description Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles. Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles. Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
18 - 40 years
2
  13.3%
1
   6.7%
3
  10.0%
41 - 64 years
4
  26.7%
9
  60.0%
13
  43.3%
Greater than or equal to (>=) 65 years
9
  60.0%
5
  33.3%
14
  46.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
1
   6.7%
5
  33.3%
6
  20.0%
Male
14
  93.3%
10
  66.7%
24
  80.0%
1.Primary Outcome
Title Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL)
Hide Description [Not Specified]
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The primary pharmacokinetic (PK) analysis population consisted of all participants with a measurable PK samples on Day 43.
Arm/Group Title Pertuzumab 840/420 mg Pertuzumab 840/840 mg
Hide Arm/Group Description:
Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles.
Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles.
Overall Number of Participants Analyzed 15 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.6
(78.3 to 99.2)
98.3
(91.4 to 99.97)
2.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.
Time Frame From randomization of first participant to end of study (approximately 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study treatment.
Arm/Group Title Pertuzumab 840/420 mg Pertuzumab 840/840 mg
Hide Arm/Group Description:
Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles.
Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles.
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: participants
15 15
Time Frame From randomization of first participant to end of study (approximately 6 years)
Adverse Event Reporting Description An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.
 
Arm/Group Title Pertuzumab 840/420 mg Pertuzumab 840/840 mg
Hide Arm/Group Description Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) Q3W for subsequent cycles. Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg Q3W for subsequent cycles.
All-Cause Mortality
Pertuzumab 840/420 mg Pertuzumab 840/840 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   10/15 (66.67%)   9/15 (60.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Pertuzumab 840/420 mg Pertuzumab 840/840 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   11/15 (73.33%)   10/15 (66.67%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  4/15 (26.67%)  0/15 (0.00%) 
Cardiac disorders     
Cardiac failure acute  1  1/15 (6.67%)  0/15 (0.00%) 
Gastrointestinal disorders     
Ascites  1  1/15 (6.67%)  0/15 (0.00%) 
Diarrhoea  1  2/15 (13.33%)  3/15 (20.00%) 
Dyspepsia  1  0/15 (0.00%)  1/15 (6.67%) 
Gastric haemorrhage  1  1/15 (6.67%)  0/15 (0.00%) 
Ileus  1  1/15 (6.67%)  0/15 (0.00%) 
Nausea  1  1/15 (6.67%)  0/15 (0.00%) 
Obstruction gastric  1  1/15 (6.67%)  1/15 (6.67%) 
Upper gastrointestinal haemorrhage  1  1/15 (6.67%)  0/15 (0.00%) 
Vomiting  1  2/15 (13.33%)  0/15 (0.00%) 
General disorders     
Asthenia  1  2/15 (13.33%)  0/15 (0.00%) 
Fatigue  1  1/15 (6.67%)  1/15 (6.67%) 
Mucosal inflammation  1  2/15 (13.33%)  0/15 (0.00%) 
Pyrexia  1  1/15 (6.67%)  0/15 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  0/15 (0.00%)  1/15 (6.67%) 
Infections and infestations     
Biliary sepsis  1  0/15 (0.00%)  1/15 (6.67%) 
Biliary tract infection  1  0/15 (0.00%)  1/15 (6.67%) 
Erysipelas  1  0/15 (0.00%)  1/15 (6.67%) 
Herpes zoster  1  1/15 (6.67%)  0/15 (0.00%) 
Peritonitis  1  1/15 (6.67%)  0/15 (0.00%) 
Pneumonia  1  1/15 (6.67%)  1/15 (6.67%) 
Pneumonia fungal  1  0/15 (0.00%)  1/15 (6.67%) 
Injury, poisoning and procedural complications     
Accident  1  1/15 (6.67%)  0/15 (0.00%) 
Investigations     
Ejection fraction decreased  1  1/15 (6.67%)  0/15 (0.00%) 
Myoglobin blood increased  1  1/15 (6.67%)  0/15 (0.00%) 
Neutrophil count decreased  1  2/15 (13.33%)  0/15 (0.00%) 
Platelet count decreased  1  1/15 (6.67%)  0/15 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/15 (0.00%)  1/15 (6.67%) 
Food intolerance  1  1/15 (6.67%)  0/15 (0.00%) 
Hyponatraemia  1  2/15 (13.33%)  0/15 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  0/15 (0.00%)  1/15 (6.67%) 
Dizziness  1  1/15 (6.67%)  0/15 (0.00%) 
Renal and urinary disorders     
Azotaemia  1  1/15 (6.67%)  0/15 (0.00%) 
Renal failure  1  0/15 (0.00%)  1/15 (6.67%) 
Acute kidney injury  1  1/15 (6.67%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1  0/15 (0.00%)  1/15 (6.67%) 
Pulmonary embolism  1  1/15 (6.67%)  1/15 (6.67%) 
Vascular disorders     
Embolism  1  0/15 (0.00%)  1/15 (6.67%) 
1
Term from vocabulary, medDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pertuzumab 840/420 mg Pertuzumab 840/840 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   15/15 (100.00%)   15/15 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  9/15 (60.00%)  11/15 (73.33%) 
Febrile Neutropenia  1  0/15 (0.00%)  2/15 (13.33%) 
Leukocytosis  1  1/15 (6.67%)  0/15 (0.00%) 
Leukopenia  1  2/15 (13.33%)  0/15 (0.00%) 
Neutrophilia  1  1/15 (6.67%)  0/15 (0.00%) 
Thrombocytopenia  1  3/15 (20.00%)  0/15 (0.00%) 
Cardiac disorders     
Cardiomyopathy  1  0/15 (0.00%)  1/15 (6.67%) 
Ear and labyrinth disorders     
Tinnitus  1  0/15 (0.00%)  1/15 (6.67%) 
Endocrine disorders     
Hyperthyroidism  1  0/15 (0.00%)  1/15 (6.67%) 
Eye disorders     
Dry eye  1  1/15 (6.67%)  0/15 (0.00%) 
Lacrimation increased  1  1/15 (6.67%)  0/15 (0.00%) 
Glaucoma  1  1/15 (6.67%)  0/15 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  5/15 (33.33%)  5/15 (33.33%) 
Abdominal pain upper  1  4/15 (26.67%)  0/15 (0.00%) 
Ascites  1  1/15 (6.67%)  1/15 (6.67%) 
Cheilitis  1  0/15 (0.00%)  1/15 (6.67%) 
Colitis  1  1/15 (6.67%)  0/15 (0.00%) 
Constipation  1  3/15 (20.00%)  1/15 (6.67%) 
Diarrhoea  1  14/15 (93.33%)  11/15 (73.33%) 
Dry mouth  1  2/15 (13.33%)  0/15 (0.00%) 
Dyspepsia  1  3/15 (20.00%)  5/15 (33.33%) 
Enteritis  1  1/15 (6.67%)  0/15 (0.00%) 
Eructation  1  1/15 (6.67%)  0/15 (0.00%) 
Gastric ulcer  1  0/15 (0.00%)  1/15 (6.67%) 
Gastrointestinal pain  1  1/15 (6.67%)  0/15 (0.00%) 
Ileus  1  0/15 (0.00%)  1/15 (6.67%) 
Nausea  1  11/15 (73.33%)  13/15 (86.67%) 
Oesophagitis  1  0/15 (0.00%)  1/15 (6.67%) 
Pancreatitis  1  0/15 (0.00%)  1/15 (6.67%) 
Stomatits  1  9/15 (60.00%)  6/15 (40.00%) 
Tooth loss  1  0/15 (0.00%)  1/15 (6.67%) 
Upper gastrointestinal haemorrhage  1  0/15 (0.00%)  1/15 (6.67%) 
Vomiting  1  9/15 (60.00%)  3/15 (20.00%) 
Dysphagia  1  0/15 (0.00%)  1/15 (6.67%) 
General disorders     
Adverse drug reaction  1  0/15 (0.00%)  1/15 (6.67%) 
Asthenia  1  6/15 (40.00%)  3/15 (20.00%) 
Catheter site pain  1  0/15 (0.00%)  2/15 (13.33%) 
Chest pain  1  0/15 (0.00%)  2/15 (13.33%) 
Chills  1  2/15 (13.33%)  1/15 (6.67%) 
Face oedema  1  2/15 (13.33%)  1/15 (6.67%) 
Fatigue  1  5/15 (33.33%)  7/15 (46.67%) 
General physical health deterioration  1  0/15 (0.00%)  1/15 (6.67%) 
Influenza like illness  1  2/15 (13.33%)  0/15 (0.00%) 
Injection site reaction  1  0/15 (0.00%)  1/15 (6.67%) 
Mucosal inflammation  1  4/15 (26.67%)  2/15 (13.33%) 
Oedema peripheral  1  5/15 (33.33%)  4/15 (26.67%) 
Pain  1  1/15 (6.67%)  3/15 (20.00%) 
Pyrexia  1  6/15 (40.00%)  2/15 (13.33%) 
Xerosis  1  0/15 (0.00%)  1/15 (6.67%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/15 (0.00%)  1/15 (6.67%) 
Hyperbilirubinaemia  1  1/15 (6.67%)  0/15 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  2/15 (13.33%)  2/15 (13.33%) 
Infections and infestations     
Bronchitis  1  1/15 (6.67%)  0/15 (0.00%) 
Cellulitis  1  1/15 (6.67%)  0/15 (0.00%) 
Cystitis  1  1/15 (6.67%)  0/15 (0.00%) 
Gingivitis  1  0/15 (0.00%)  1/15 (6.67%) 
Hepatitis B  1  1/15 (6.67%)  0/15 (0.00%) 
Herpes Simplex  1  1/15 (6.67%)  0/15 (0.00%) 
Herpes virus infection  1  0/15 (0.00%)  1/15 (6.67%) 
Nasopharyngitis  1  3/15 (20.00%)  1/15 (6.67%) 
Oral herpes  1  0/15 (0.00%)  1/15 (6.67%) 
Paronychia  1  0/15 (0.00%)  1/15 (6.67%) 
Pneumonia  1  2/15 (13.33%)  0/15 (0.00%) 
Tinea versicolour  1  0/15 (0.00%)  1/15 (6.67%) 
Toxocariasis  1  0/15 (0.00%)  1/15 (6.67%) 
Upper respiratory tract infection  1  1/15 (6.67%)  1/15 (6.67%) 
Urinary tract infection  1  0/15 (0.00%)  1/15 (6.67%) 
Vaginal infection  1  1/15 (6.67%)  0/15 (0.00%) 
Injury, poisoning and procedural complications     
Allergic transfusion reaction  1  0/15 (0.00%)  1/15 (6.67%) 
Contusion  1  1/15 (6.67%)  0/15 (0.00%) 
Infusion related reaction  1  1/15 (6.67%)  0/15 (0.00%) 
Procedural pain  1  0/15 (0.00%)  1/15 (6.67%) 
Investigations     
Activated partial thromboplastin time prolonged  1  1/15 (6.67%)  0/15 (0.00%) 
Alanine aminotransferase increased  1  2/15 (13.33%)  3/15 (20.00%) 
Amylase increased  1  0/15 (0.00%)  1/15 (6.67%) 
Aspartate aminotransferase inreased  1  1/15 (6.67%)  2/15 (13.33%) 
Bilirubin conjugated increased  1  0/15 (0.00%)  1/15 (6.67%) 
Blood bilirubin increased  1  0/15 (0.00%)  2/15 (13.33%) 
Blood cholesterol increased  1  1/15 (6.67%)  0/15 (0.00%) 
Blood cholinesterase decreased  1  2/15 (13.33%)  0/15 (0.00%) 
Blood creatine phosphokinase increased  1  1/15 (6.67%)  0/15 (0.00%) 
Blood creatine phosphokinase MB increased  1  1/15 (6.67%)  0/15 (0.00%) 
Blood creatinine increased  1  1/15 (6.67%)  0/15 (0.00%) 
Blood fibrinogen increased  1  1/15 (6.67%)  0/15 (0.00%) 
Blood iron increased  1  1/15 (6.67%)  0/15 (0.00%) 
Blood lactate dehydrogenase increased  1  1/15 (6.67%)  0/15 (0.00%) 
Blood potassium increased  1  0/15 (0.00%)  1/15 (6.67%) 
Blood urea increased  1  1/15 (6.67%)  0/15 (0.00%) 
Creatinine renal clearance decreased  1  4/15 (26.67%)  1/15 (6.67%) 
Ejection fraction decreased  1  2/15 (13.33%)  0/15 (0.00%) 
Fibrin D dimer increased  1  1/15 (6.67%)  0/15 (0.00%) 
Gamma-glutamyltransferase increased  1  0/15 (0.00%)  1/15 (6.67%) 
Glomerular filtration rate decreased  1  0/15 (0.00%)  1/15 (6.67%) 
International normalised ratio increased  1  0/15 (0.00%)  1/15 (6.67%) 
Lipase increased  1  0/15 (0.00%)  1/15 (6.67%) 
Neutrophil count decreased  1  11/15 (73.33%)  11/15 (73.33%) 
Platelet count decreased  1  1/15 (6.67%)  2/15 (13.33%) 
Protein total decreased  1  2/15 (13.33%)  0/15 (0.00%) 
Prothrombin time shortened  1  1/15 (6.67%)  0/15 (0.00%) 
Transaminases increased  1  1/15 (6.67%)  0/15 (0.00%) 
Weight decreased  1  4/15 (26.67%)  4/15 (26.67%) 
Weight increased  1  2/15 (13.33%)  1/15 (6.67%) 
White blood cell count decreased  1  0/15 (0.00%)  2/15 (13.33%) 
Urine output decreased  1  1/15 (6.67%)  0/15 (0.00%) 
Vitamin D decreased  1  1/15 (6.67%)  0/15 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  11/15 (73.33%)  9/15 (60.00%) 
Hyperglycaemia  1  2/15 (13.33%)  0/15 (0.00%) 
Hyperkalaemia  1  1/15 (6.67%)  1/15 (6.67%) 
Hyperphosphataemia  1  1/15 (6.67%)  0/15 (0.00%) 
Hypoalbuminaemia  1  4/15 (26.67%)  1/15 (6.67%) 
Hypocalcaemia  1  2/15 (13.33%)  1/15 (6.67%) 
Hypochloraemia  1  2/15 (13.33%)  0/15 (0.00%) 
Hypokalaemia  1  3/15 (20.00%)  6/15 (40.00%) 
Hypomagnesaemia  1  8/15 (53.33%)  3/15 (20.00%) 
Hyponatraemia  1  4/15 (26.67%)  0/15 (0.00%) 
Hypophosphataemia  1  2/15 (13.33%)  3/15 (20.00%) 
Hyposideraemia  1  2/15 (13.33%)  0/15 (0.00%) 
Hypovitaminosis  1  1/15 (6.67%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders     
Fracture pain  1  1/15 (6.67%)  0/15 (0.00%) 
Muscle spasms  1  1/15 (6.67%)  0/15 (0.00%) 
Muscular weakness  1  1/15 (6.67%)  1/15 (6.67%) 
Musculoskeletal pain  1  3/15 (20.00%)  1/15 (6.67%) 
Myalgia  1  4/15 (26.67%)  1/15 (6.67%) 
Pain in extremity  1  2/15 (13.33%)  1/15 (6.67%) 
Nervous system disorders     
Ageusia  1  0/15 (0.00%)  1/15 (6.67%) 
Cholinergic syndrome  1  1/15 (6.67%)  0/15 (0.00%) 
Dizziness  1  8/15 (53.33%)  3/15 (20.00%) 
Dysgeusia  1  3/15 (20.00%)  3/15 (20.00%) 
Headache  1  2/15 (13.33%)  2/15 (13.33%) 
Neuropathy peripheral  1  1/15 (6.67%)  2/15 (13.33%) 
Neurotoxicity  1  1/15 (6.67%)  0/15 (0.00%) 
Paraesthesia  1  0/15 (0.00%)  1/15 (6.67%) 
Peripheral sensory neuropathy  1  4/15 (26.67%)  4/15 (26.67%) 
Polyneuropathy  1  0/15 (0.00%)  1/15 (6.67%) 
Tension headache  1  1/15 (6.67%)  0/15 (0.00%) 
Tremor  1  0/15 (0.00%)  1/15 (6.67%) 
Psychiatric disorders     
Affective disorder  1  1/15 (6.67%)  0/15 (0.00%) 
Anxiety  1  2/15 (13.33%)  0/15 (0.00%) 
Insomnia  1  4/15 (26.67%)  2/15 (13.33%) 
Sleep disorder  1  0/15 (0.00%)  1/15 (6.67%) 
Somatic symptom disorder  1  1/15 (6.67%)  0/15 (0.00%) 
Renal and urinary disorders     
Acute prerenal failure  1  1/15 (6.67%)  0/15 (0.00%) 
Azotaemia  1  2/15 (13.33%)  0/15 (0.00%) 
Haematuria  1  1/15 (6.67%)  0/15 (0.00%) 
Pollakiuria  1  0/15 (0.00%)  1/15 (6.67%) 
Renal failure  1  1/15 (6.67%)  0/15 (0.00%) 
Acute kidney injury  1  1/15 (6.67%)  0/15 (0.00%) 
Chronic kidney disease  1  1/15 (6.67%)  0/15 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/15 (6.67%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/15 (26.67%)  3/15 (20.00%) 
Dyspnoea  1  2/15 (13.33%)  3/15 (20.00%) 
Dyspnoea exertional  1  0/15 (0.00%)  1/15 (6.67%) 
Epistaxis  1  2/15 (13.33%)  0/15 (0.00%) 
Hiccups  1  5/15 (33.33%)  0/15 (0.00%) 
Oropharyngeal pain  1  2/15 (13.33%)  2/15 (13.33%) 
Pleural effusion  1  1/15 (6.67%)  0/15 (0.00%) 
Productive cough  1  6/15 (40.00%)  1/15 (6.67%) 
Rales  1  1/15 (6.67%)  0/15 (0.00%) 
Rhinorrhoea  1  3/15 (20.00%)  4/15 (26.67%) 
Nasal inflammation  1  0/15 (0.00%)  1/15 (6.67%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  0/15 (0.00%)  1/15 (6.67%) 
Decubitus ulcer  1  0/15 (0.00%)  1/15 (6.67%) 
Dermatitis allergic  1  1/15 (6.67%)  0/15 (0.00%) 
Hyperhidrosis  1  1/15 (6.67%)  1/15 (6.67%) 
Nail ridging  1  3/15 (20.00%)  1/15 (6.67%) 
Onycholysis  1  1/15 (6.67%)  0/15 (0.00%) 
Onychomadesis  1  1/15 (6.67%)  0/15 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  5/15 (33.33%)  5/15 (33.33%) 
Pruritus  1  1/15 (6.67%)  1/15 (6.67%) 
Rash  1  1/15 (6.67%)  1/15 (6.67%) 
Skin hyperpigmentation  1  5/15 (33.33%)  3/15 (20.00%) 
Stasis dermatitis  1  0/15 (0.00%)  1/15 (6.67%) 
Urticaria  1  0/15 (0.00%)  1/15 (6.67%) 
Vascular disorders     
Deep vein thrombosis  1  1/15 (6.67%)  0/15 (0.00%) 
Embolism  1  0/15 (0.00%)  1/15 (6.67%) 
Flushing  1  0/15 (0.00%)  1/15 (6.67%) 
Hypertension  1  4/15 (26.67%)  0/15 (0.00%) 
Hypertensive crisis  1  0/15 (0.00%)  1/15 (6.67%) 
Hypotension  1  1/15 (6.67%)  0/15 (0.00%) 
Subclavian vein thrombosis  1  1/15 (6.67%)  0/15 (0.00%) 
1
Term from vocabulary, medDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01461057     History of Changes
Other Study ID Numbers: BP27836
First Submitted: October 26, 2011
First Posted: October 27, 2011
Results First Submitted: May 19, 2016
Results First Posted: June 27, 2016
Last Update Posted: August 9, 2018