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To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan (rituximab)

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ClinicalTrials.gov Identifier: NCT02162771
Recruitment Status : Completed
First Posted : June 13, 2014
Results First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Celltrion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lymphoma, Follicular
Interventions Biological: Rituxan
Biological: CT-P10
Drug: Cyclophosphamide
Drug: Vincristine
Drug: Prednisone
Enrollment 140
Recruitment Details  
Pre-assignment Details A total of 184 participants were screened for the study. Of those, 44 participants failed screening and 140 participants were enrolled in the study.
Arm/Group Title CT-P10 Rituxan
Hide Arm/Group Description

Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Period Title: Core Study Period (Part 2)
Started 70 70
Completed 62 62
Not Completed 8 8
Reason Not Completed
Progressive Disease             2             3
Adverse Event             4             1
Withdrawal by Subject             1             2
Physician Decision             0             2
Death             1             0
Period Title: Maintenance Study Period (Part 2)
Started 62 60 [1]
Completed 46 38
Not Completed 16 22
Reason Not Completed
Progressive Disease             11             13
Adverse Event             3             3
Death             2             1
Withdrawal by Subject             0             3
Protocol Violation             0             1
Stable Disease             0             1
[1]
Two subjects did not enter this period due to Withdrawal by subject and Non-responder, 1 for each.
Arm/Group Title CT-P10 Rituxan Total
Hide Arm/Group Description

Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Total of all reporting groups
Overall Number of Baseline Participants 70 70 140
Hide Baseline Analysis Population Description
All randomized patients (ITT population)
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 70 participants 70 participants 140 participants
57.0
(30 to 85)
58.5
(26 to 84)
57.5
(26 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
Female
40
  57.1%
37
  52.9%
77
  55.0%
Male
30
  42.9%
33
  47.1%
63
  45.0%
1.Primary Outcome
Title Area Under the Serum Concentration-time Curve at Steady State (AUCtau)
Hide Description

AUCtau: Area under the plasma drug concentration-time curve within a dosing interval at steady state.

PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.

Time Frame Core Cycle 4 (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population consisted of all patients who had at least 1 posttreatment PK concentration result after receiving at least 1 dose of study drug (CT-P10 or Rituxan) in Part 1. Patients considered outliers identified by a robust regression model (95% CI) were excluded from the analysis.
Arm/Group Title CT-P10 Rituxan
Hide Arm/Group Description:

Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Overall Number of Participants Analyzed 50 56
Geometric Mean (Standard Error)
Unit of Measure: h*ug/mL
41002.43  (1.136) 40099.08  (1.143)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CT-P10, Rituxan
Comments Equivalence in AUCtau between CT-P10 and Rituxan
Type of Statistical Test Equivalence
Comments The 90% CIs of the ratios of geometric means of log-transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.
Method of Estimation Estimation Parameter Ratio of geometric least square means
Estimated Value 102.25
Confidence Interval (2-Sided) 90%
94.05 to 111.17
Estimation Comments [Not Specified]
2.Primary Outcome
Title Maximum Serum Concentration at Steady State (Cmax,ss)
Hide Description

Cmax,ss: Maximum concentration of drug in plasma at steady state on administering a fixed dose at equal dosing intervals.

PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.

Time Frame Core Cycle 4 (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population consisted of all patients who had at least 1 posttreatment PK concentration result after receiving at least 1 dose of study drug (CT-P10 or Rituxan) in Part 1. Patients considered outliers identified by a robust regression model (95% CI) were excluded from the analysis.
Arm/Group Title CT-P10 Rituxan
Hide Arm/Group Description:

Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Overall Number of Participants Analyzed 53 56
Geometric Mean (Standard Error)
Unit of Measure: ug/mL
256.19  (1.115) 254.49  (1.120)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CT-P10, Rituxan
Comments Equivalence in Cmax,ss between CT-P10 and Rituxan
Type of Statistical Test Equivalence
Comments The 90% CIs of the ratios of geometric means of log-transformed transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.
Method of Estimation Estimation Parameter Ratio of geometric least square means
Estimated Value 100.67
Confidence Interval (2-Sided) 90%
93.84 to 108.00
Estimation Comments [Not Specified]
3.Primary Outcome
Title Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria
Hide Description

ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) by central review.

Per 1999 IWG criteria, the disease status was assessed by using contrasted CT, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: >=75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: >=50% decrease in SPD of target lesions and no evidence of disease progression.

Time Frame During the Core Study Period (up to 8 cycles; Week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of all patients who had at least 1 response evaluation after receiving at least 1 treatment cycle in the Core Study Period without any major protocol deviation that was relevant to the efficacy endpoint in Part 2.
Arm/Group Title CT-P10 Rituxan
Hide Arm/Group Description:

Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Overall Number of Participants Analyzed 66 68
Measure Type: Count of Participants
Unit of Measure: Participants
64
  97.0%
63
  92.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CT-P10, Rituxan
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority margin of -7% was predefined.
Method of Estimation Estimation Parameter Point estimate difference
Estimated Value 4.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title B-cell Kinetics (B-cell Depletion and Recovery)
Hide Description B-cell kinetics were demonstrated by median values of B-cell counts (Lower limit of quantification was 20 cells/uL).
Time Frame Cycles 1 to 8 during the Core Study Period
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) population consisted of all patients who had at least 1 posttreatment PD result after receiving at least 1 dose of study drug (CT-P10 or Rituxan) without any major protocol deviation that was relevant to the PD endpoint in Part 2.
Arm/Group Title CT-P10 Rituxan
Hide Arm/Group Description:

Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Overall Number of Participants Analyzed 70 70
Median (Full Range)
Unit of Measure: cells/uL
Core Cycle 1 (Predose) Number Analyzed 56 participants 57 participants
92.5
(20 to 2890)
62.0
(20 to 2890)
Core Cycle 1 (1 hour after the end of infusion) Number Analyzed 44 participants 55 participants
20.0
(20 to 1108)
20.0
(20 to 51)
Core Cycle 2 (Predose) Number Analyzed 60 participants 60 participants
20.0
(20 to 1750)
20.0
(20 to 2890)
Core Cycle 3 (Predose) Number Analyzed 63 participants 62 participants
20.0
(20 to 231)
20.0
(20 to 35)
Core Cycle 4 (Predose) Number Analyzed 59 participants 61 participants
20.0
(20 to 51)
20.0
(20 to 20)
Core Cycle 5 (Predose) Number Analyzed 60 participants 57 participants
20.0
(20 to 20)
20.0
(20 to 20)
Core Cycle 6 (Predose) Number Analyzed 60 participants 61 participants
20.0
(20 to 33)
20.0
(20 to 20)
Core Cycle 7 (Predose) Number Analyzed 60 participants 63 participants
20.0
(20 to 24)
20.0
(20 to 20)
Core Cycle 8 (Predose) Number Analyzed 61 participants 59 participants
20.0
(20 to 20)
20.0
(20 to 20)
Time Frame Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from last dose of the study drug, regardless of relationship to the study drug (a median follow up of 39.9 months).
Adverse Event Reporting Description All TESAEs and non-serious AEs reported for more than 5% of the patients in either treatment group were summarized for the safety population. Safety population consisted of all patients who received at least 1 dose of the study drug (CT-P10 or Rituxan). Grading for severity and terminology of AEs were described according to the CTCAE Version 4.0.
 
Arm/Group Title CT-P10 Rituxan
Hide Arm/Group Description

Patient treated with CT-P10 (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with CT-P10 (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

Patient treated with Rituxan (375 mg/m2 IV) in combination with cyclophosphamide (750 mg/m2 IV), vincristine (1.4 mg/m2 [max 2 mg] IV), and prednisone 40 mg/m2 orally) up to 8 cycles every 3 weeks during the Core Study Period.

Patients having responses during Core Study Period treated with Rituxan (375 mg/m2 IV) monotherapy up to 12 cycles every 2 months during the Maintenance Study Period.

All-Cause Mortality
CT-P10 Rituxan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
CT-P10 Rituxan
Affected / at Risk (%) Affected / at Risk (%)
Total   24/70 (34.29%)   13/70 (18.57%) 
Blood and lymphatic system disorders     
Anaemia  1  1/70 (1.43%)  0/70 (0.00%) 
Febrile neutropenia  1  2/70 (2.86%)  3/70 (4.29%) 
Leukopenia  1  0/70 (0.00%)  1/70 (1.43%) 
Neutropenia  1  1/70 (1.43%)  1/70 (1.43%) 
Pancytopenia  1  1/70 (1.43%)  0/70 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  1/70 (1.43%)  0/70 (0.00%) 
Tachycardia  1  0/70 (0.00%)  1/70 (1.43%) 
Gastrointestinal disorders     
Constipation  1  1/70 (1.43%)  0/70 (0.00%) 
Diarrhea  1  0/70 (0.00%)  1/70 (1.43%) 
Ileus  1  0/70 (0.00%)  1/70 (1.43%) 
Small intestinal perforation  1  1/70 (1.43%)  0/70 (0.00%) 
General disorders     
Pyrexia  1  0/70 (0.00%)  1/70 (1.43%) 
Hepatobiliary disorders     
Cholecystitis  1  1/70 (1.43%)  0/70 (0.00%) 
Immune system disorders     
Anaphylactic shock  1  1/70 (1.43%)  0/70 (0.00%) 
Infections and infestations     
Abdominal infection  1  1/70 (1.43%)  0/70 (0.00%) 
Appendicitis  1  1/70 (1.43%)  0/70 (0.00%) 
Campylobacter gastroenteritis  1  1/70 (1.43%)  0/70 (0.00%) 
Encephalitis  1  0/70 (0.00%)  1/70 (1.43%) 
Herpes virus infection  1  1/70 (1.43%)  0/70 (0.00%) 
Lower respiratory tract infection  1  1/70 (1.43%)  2/70 (2.86%) 
Pneumonia  1  4/70 (5.71%)  1/70 (1.43%) 
Sialodenitis  1  1/70 (1.43%)  0/70 (0.00%) 
Upper respiratory tract infection  1  0/70 (0.00%)  2/70 (2.86%) 
Injury, poisoning and procedural complications     
Fracture  1  1/70 (1.43%)  0/70 (0.00%) 
Injury  1  1/70 (1.43%)  0/70 (0.00%) 
Post procedural fistula  1  1/70 (1.43%)  0/70 (0.00%) 
Subdural haematoma  1  0/70 (0.00%)  1/70 (1.43%) 
Investigations     
Liver function test abnormal  1  1/70 (1.43%)  0/70 (0.00%) 
Metabolism and nutrition disorders     
Hypoalbuminaemia  1  1/70 (1.43%)  0/70 (0.00%) 
Hypocalcaemia  1  1/70 (1.43%)  0/70 (0.00%) 
Hypomagnesaemia  1  1/70 (1.43%)  0/70 (0.00%) 
Tumour lysis syndrome  1  1/70 (1.43%)  0/70 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma gastric  1  1/70 (1.43%)  0/70 (0.00%) 
Hepatocellular carcinoma  1  1/70 (1.43%)  0/70 (0.00%) 
Invasive lobular breast carcinoma  1  1/70 (1.43%)  0/70 (0.00%) 
Prostate cancer metastatic  1  1/70 (1.43%)  0/70 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/70 (0.00%)  1/70 (1.43%) 
Chronic obstructive pulmonary disease  1  2/70 (2.86%)  1/70 (1.43%) 
Pleural effusion  1  1/70 (1.43%)  0/70 (0.00%) 
Pulmonary embolism  1  1/70 (1.43%)  0/70 (0.00%) 
Respiratory failure  1  1/70 (1.43%)  0/70 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/70 (1.43%)  0/70 (0.00%) 
Hypertension  1  1/70 (1.43%)  0/70 (0.00%) 
Peripheral ischaemia  1  0/70 (0.00%)  1/70 (1.43%) 
Thrombophlebitis  1  0/70 (0.00%)  1/70 (1.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CT-P10 Rituxan
Affected / at Risk (%) Affected / at Risk (%)
Total   58/70 (82.86%)   57/70 (81.43%) 
Blood and lymphatic system disorders     
Anaemia  1  6/70 (8.57%)  5/70 (7.14%) 
Neutropenia  1  27/70 (38.57%)  20/70 (28.57%) 
Gastrointestinal disorders     
Abdominal pain  1  8/70 (11.43%)  11/70 (15.71%) 
Constipation  1  12/70 (17.14%)  10/70 (14.29%) 
Diarrhoea  1  6/70 (8.57%)  7/70 (10.00%) 
Nausea  1  9/70 (12.86%)  7/70 (10.00%) 
Stomatitis  1  2/70 (2.86%)  4/70 (5.71%) 
General disorders     
Asthenia  1  5/70 (7.14%)  8/70 (11.43%) 
Fatigue  1  6/70 (8.57%)  8/70 (11.43%) 
Oedema  1  5/70 (7.14%)  3/70 (4.29%) 
Pyrexia  1  3/70 (4.29%)  6/70 (8.57%) 
Infections and infestations     
Fungal infection  1  4/70 (5.71%)  4/70 (5.71%) 
Influenza  1  2/70 (2.86%)  4/70 (5.71%) 
Lower respiratory tract infection  1  7/70 (10.00%)  1/70 (1.43%) 
Sinusitis  1  5/70 (7.14%)  2/70 (2.86%) 
Upper respiratory tract infection  1  14/70 (20.00%)  18/70 (25.71%) 
Urinary tract infection  1  6/70 (8.57%)  6/70 (8.57%) 
Injury, poisoning and procedural complications     
Fracture  1  4/70 (5.71%)  1/70 (1.43%) 
Infusion related reaction  1  16/70 (22.86%)  19/70 (27.14%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/70 (0.00%)  6/70 (8.57%) 
Hyperglycaemia  1  2/70 (2.86%)  5/70 (7.14%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/70 (10.00%)  4/70 (5.71%) 
Back pain  1  2/70 (2.86%)  12/70 (17.14%) 
Myalgia  1  6/70 (8.57%)  2/70 (2.86%) 
Nervous system disorders     
Dizziness  1  4/70 (5.71%)  5/70 (7.14%) 
Headache  1  4/70 (5.71%)  6/70 (8.57%) 
Hypoaesthesia  1  6/70 (8.57%)  2/70 (2.86%) 
Neuropathy peripheral  1  10/70 (14.29%)  12/70 (17.14%) 
Paraesthesia  1  3/70 (4.29%)  8/70 (11.43%) 
Psychiatric disorders     
Insomnia  1  2/70 (2.86%)  6/70 (8.57%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  6/70 (8.57%)  5/70 (7.14%) 
Dyspnoea  1  4/70 (5.71%)  1/70 (1.43%) 
Oropharyngeal pain  1  1/70 (1.43%)  4/70 (5.71%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  10/70 (14.29%)  5/70 (7.14%) 
Vascular disorders     
Hypertension  1  6/70 (8.57%)  3/70 (4.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
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.
Confidentiality and non-disclosure agreement (CDA) was executed between Celltrion, Inc. and some PIs who have participated in publications funded by the sponsor for academic purposes for a period that is more than 180 days from the time submitted to the sponsor for review.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sung Hyun Kim
Organization: CELLTRION, Inc.
Phone: +82-32-850-5000
EMail: contact@celltrion.com
Layout table for additonal information
Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT02162771    
Other Study ID Numbers: CT-P10 3.3
2013-004493-96 ( EudraCT Number )
First Submitted: May 29, 2014
First Posted: June 13, 2014
Results First Submitted: December 26, 2019
Results First Posted: January 29, 2020
Last Update Posted: January 29, 2020