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Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma (ORIENTAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01465464
Recruitment Status : Terminated
First Posted : November 4, 2011
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hepatocellular Carcinoma
Interventions Drug: Orantinib (TSU-68)
Drug: Placebo
Enrollment 888
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Orantinib Placebo
Hide Arm/Group Description Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening. Placebo: 1 tablet was administered orally twice per day after meals, morning and evening.
Period Title: Overall Study
Started 444 444
Completed 0 0
Not Completed 444 444
Reason Not Completed
Adverse Event             96             49
Lack of Efficacy             139             190
Physician Decision             13             5
Protocol Violation             1             1
Withdrawal by Subject             46             30
Other             9             3
Ongoing treatment at cutoff date             140             166
Arm/Group Title Orantinib Placebo Total
Hide Arm/Group Description Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening. Placebo: 1 tablet was administered orally twice per day after meals, morning and evening. Total of all reporting groups
Overall Number of Baseline Participants 444 444 888
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 444 participants 444 participants 888 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
189
  42.6%
202
  45.5%
391
  44.0%
>=65 years
255
  57.4%
242
  54.5%
497
  56.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 444 participants 444 participants 888 participants
Female
81
  18.2%
80
  18.0%
161
  18.1%
Male
363
  81.8%
364
  82.0%
727
  81.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 444 participants 444 participants 888 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
444
 100.0%
444
 100.0%
888
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 444 participants 444 participants 888 participants
South Korea 170 170 340
Japan 219 213 432
Taiwan 55 61 116
1.Primary Outcome
Title Overall Survival(OS)
Hide Description [Not Specified]
Time Frame The time from the date of enrollment to the date of death from any cause, assessed up to three years after randomizationof the last patient
Hide Outcome Measure Data
Hide Analysis Population Description

When approximately 50% of the targeted number of time to TACE discontinuation events were confirmed, interim analysis was performed by IDMC.

Because the Committee considered that significant results would no longer be obtained, the IDMC recommended to the Sponsor that the clinical trial would be discontinued, and the Sponsor stopped this trial.

Arm/Group Title Orantinib Placebo
Hide Arm/Group Description:
Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
Placebo: 1 tablet was administered orally twice per day after meals, morning and evening.
Overall Number of Participants Analyzed 168 163
Median (95% Confidence Interval)
Unit of Measure: days
946.0
(807.0 to 1050.0)
984.0 [1] 
(864.0 to NA)
[1]
The upper limit of median OS didn't reach.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.435
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.090
Confidence Interval (2-Sided) 95%
0.878 to 1.352
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Transcatheter Arterial Chemoembolization (TACE) Failure
Hide Description

Patients should not receive additional TACE therapy in this study after meeting any of the following conditions, at the Investigator's discretion.

  1. The patient develops an intra-hepatic lesion that is uncontrolled by serial TACE
  2. Deterioration in arterial pathways to treat HCC that makes additional TACE impossible
  3. Severe vascular invasion occurs that makes additional TACE impossible
  4. Extra hepatic spread considered relevant to life expectancy that requires another treatment modality for HCC
  5. Liver function at grade Child-Pugh class C lasting for 28 days
Time Frame The time from the date of enrollment to the date of event for TACE discontinuation, assessed up to three years after randomizationof the last patient
Hide Outcome Measure Data
Hide Analysis Population Description

When approximately 50% of the targeted number of time to TACE discontinuation events were confirmed, interim analysis was performed by IDMC.

Because the Committee considered that significant results would no longer be obtained, the IDMC recommended to the Sponsor that the clinical trial would be discontinued, and the Sponsor stopped this trial.

Arm/Group Title Orantinib Placebo
Hide Arm/Group Description:
Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
Placebo: 1 tablet was administered orally twice per day after meals, morning and evening.
Overall Number of Participants Analyzed 174 206
Median (95% Confidence Interval)
Unit of Measure: days
728.0
(604.0 to 813.0)
602.0
(539.0 to 724.0)
Time Frame From the date of the first treatment to 30 days after the last treatment
Adverse Event Reporting Description

Main treatment discontinuation criteria

  • The Investigator concludes that the patients should be treated with another treatment modality except TACE for HCC
  • Patient has unacceptable/intolerable toxicities
  • Patient can not take both enhanced CT and enhanced MRI of the abdomen any more
  • Patient wishes to discontinue the treatment
 
Arm/Group Title Orantinib Placebo
Hide Arm/Group Description Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening. Placebo: 1 tablet was administered orally twice per day after meals, morning and evening.
All-Cause Mortality
Orantinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   33/444 (7.43%)   24/444 (5.41%) 
Hide Serious Adverse Events
Orantinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   200/444 (45.05%)   134/444 (30.18%) 
Blood and lymphatic system disorders     
Anaemia  1  3/444 (0.68%)  0/444 (0.00%) 
Disseminated intravascular coagulation  1  2/444 (0.45%)  0/444 (0.00%) 
Leukocytosis  1  1/444 (0.23%)  0/444 (0.00%) 
Idiopathic thrombocytopenic purpura  1  0/444 (0.00%)  1/444 (0.23%) 
Cardiac disorders     
Acute pericarditis  1  1/444 (0.23%)  0/444 (0.00%) 
Angina pectoris  1  1/444 (0.23%)  0/444 (0.00%) 
Atrial thrombosis  1  1/444 (0.23%)  0/444 (0.00%) 
Cardiopulmonary arrest  1  1/444 (0.23%)  0/444 (0.00%) 
Heart failure  1  1/444 (0.23%)  0/444 (0.00%) 
Left ventricular dysfunction  1  1/444 (0.23%)  0/444 (0.00%) 
Myocardial infarction  1  3/444 (0.68%)  0/444 (0.00%) 
Paroxysmal supraventricular tachycardia  1  1/444 (0.23%)  0/444 (0.00%) 
Pericardial effusion  1  1/444 (0.23%)  0/444 (0.00%) 
Acute myocardial infarction  1  0/444 (0.00%)  1/444 (0.23%) 
Congenital, familial and genetic disorders     
Hydrocele cord  1  1/444 (0.23%)  0/444 (0.00%) 
Endocrine disorders     
Hypothyroidism  1  0/444 (0.00%)  1/444 (0.23%) 
Eye disorders     
Cataract  1  4/444 (0.90%)  3/444 (0.68%) 
Cataract aggravated  1  3/444 (0.68%)  1/444 (0.23%) 
Diabetic retinopathy  1  0/444 (0.00%)  1/444 (0.23%) 
Retinal macroaneurysm  1  0/444 (0.00%)  1/444 (0.23%) 
Gastrointestinal disorders     
Abdominal pain  1  9/444 (2.03%)  7/444 (1.58%) 
Acute pancreatitis  1  1/444 (0.23%)  0/444 (0.00%) 
Anal fistula  1  1/444 (0.23%)  0/444 (0.00%) 
Acute gastric ulcer with haemorrhage  1  0/444 (0.00%)  1/444 (0.23%) 
Ascites  1  19/444 (4.28%)  11/444 (2.48%) 
Colonic polyp  1  1/444 (0.23%)  0/444 (0.00%) 
Dental caries  1  2/444 (0.45%)  0/444 (0.00%) 
Diarrhea  1  4/444 (0.90%)  2/444 (0.45%) 
Duodenal ulcer  1  2/444 (0.45%)  0/444 (0.00%) 
Duodenal ulcer hemorrhage  1  1/444 (0.23%)  1/444 (0.23%) 
Epigastric pain  1  1/444 (0.23%)  0/444 (0.00%) 
Esophageal hemorrhage  1  1/444 (0.23%)  0/444 (0.00%) 
Esophageal varices hemorrhage  1  6/444 (1.35%)  7/444 (1.58%) 
Enterocolitis  1  0/444 (0.00%)  1/444 (0.23%) 
Gastric varices bleeding  1  1/444 (0.23%)  0/444 (0.00%) 
Gastric varices haemorrhage  1  2/444 (0.45%)  7/444 (1.58%) 
Gastroduodenal ulcer  1  1/444 (0.23%)  1/444 (0.23%) 
Gastroesophageal varices hemorrhage  1  1/444 (0.23%)  0/444 (0.00%) 
Gastric perforation  1  0/444 (0.00%)  1/444 (0.23%) 
Gastrointestinal hemorrhage  1  0/444 (0.00%)  2/444 (0.45%) 
Incarcerated inguinal hernia  1  1/444 (0.23%)  0/444 (0.00%) 
Inguinal hernia  1  1/444 (0.23%)  2/444 (0.45%) 
Irritable bowel syndrome  1  1/444 (0.23%)  0/444 (0.00%) 
Ischemia bowel  1  1/444 (0.23%)  0/444 (0.00%) 
Ischemic enterocolitis  1  1/444 (0.23%)  0/444 (0.00%) 
Large intestine polyp  1  1/444 (0.23%)  0/444 (0.00%) 
Melaena  1  1/444 (0.23%)  0/444 (0.00%) 
Hematemesis  1  0/444 (0.00%)  1/444 (0.23%) 
Intestinal obstruction  1  0/444 (0.00%)  1/444 (0.23%) 
Intra-abdominal haemorrhage  1  0/444 (0.00%)  1/444 (0.23%) 
Mallory-Weiss syndrome  1  0/444 (0.00%)  1/444 (0.23%) 
Mouth haemorrhage  1  0/444 (0.00%)  1/444 (0.23%) 
Nausea  1  1/444 (0.23%)  0/444 (0.00%) 
Oesophageal varices haemorrhage  1  6/444 (1.35%)  7/444 (1.58%) 
Pancreatitis  1  2/444 (0.45%)  0/444 (0.00%) 
Periodontal disease  1  1/444 (0.23%)  0/444 (0.00%) 
Right upper quadrant pain  1  1/444 (0.23%)  1/444 (0.23%) 
Ulcer duodenal haemorrhage  1  1/444 (0.23%)  0/444 (0.00%) 
Upper gastrointestinal hemorrhage  1  1/444 (0.23%)  1/444 (0.23%) 
Varices oesophageal  1  1/444 (0.23%)  6/444 (1.35%) 
Vomiting  1  3/444 (0.68%)  0/444 (0.00%) 
General disorders     
Condition aggravated  1  1/444 (0.23%)  0/444 (0.00%) 
Disease progression  1  2/444 (0.45%)  0/444 (0.00%) 
Edema limbs  1  2/444 (0.45%)  1/444 (0.23%) 
Fever  1  13/444 (2.93%)  11/444 (2.48%) 
Gait disturbance  1  1/444 (0.23%)  0/444 (0.00%) 
Malaise  1  3/444 (0.68%)  0/444 (0.00%) 
Multi organ failure  1  1/444 (0.23%)  0/444 (0.00%) 
Pain  1  1/444 (0.23%)  0/444 (0.00%) 
Weakness generalised  1  5/444 (1.13%)  0/444 (0.00%) 
Fatigue  1  0/444 (0.00%)  2/444 (0.45%) 
Hepatobiliary disorders     
Acute cholecystitis  1  1/444 (0.23%)  0/444 (0.00%) 
Acute hepatic failure  1  2/444 (0.45%)  1/444 (0.23%) 
Bile duct stenosis  1  1/444 (0.23%)  5/444 (1.13%) 
Biliary fistula  1  1/444 (0.23%)  0/444 (0.00%) 
Biloma  1  5/444 (1.13%)  1/444 (0.23%) 
Cholangitis  1  5/444 (1.13%)  2/444 (0.45%) 
Cholangitis acute  1  1/444 (0.23%)  2/444 (0.45%) 
Cholecystitis  1  3/444 (0.68%)  4/444 (0.90%) 
Dilatation intrahepatic duct acquired  1  1/444 (0.23%)  0/444 (0.00%) 
Gallbladder perforation  1  0/444 (0.00%)  1/444 (0.23%) 
Haemobilia  1  0/444 (0.00%)  2/444 (0.45%) 
Hepatic failure  1  16/444 (3.60%)  11/444 (2.48%) 
Hepatic function disorder  1  11/444 (2.48%)  4/444 (0.90%) 
Hepatic necrosis  1  1/444 (0.23%)  1/444 (0.23%) 
Hepatopathy  1  0/444 (0.00%)  2/444 (0.45%) 
Hyperbilirubinemia  1  1/444 (0.23%)  2/444 (0.45%) 
Jaundice  1  1/444 (0.23%)  2/444 (0.45%) 
Obstructive jaundice  1  0/444 (0.00%)  1/444 (0.23%) 
Portal vein thrombosis  1  2/444 (0.45%)  2/444 (0.45%) 
Hepatic vein thrombosis  1  1/444 (0.23%)  0/444 (0.00%) 
Hepatorenal syndrome  1  6/444 (1.35%)  0/444 (0.00%) 
Appendicitis perforated  1  2/444 (0.45%)  1/444 (0.23%) 
Bacteremia  1  3/444 (0.68%)  3/444 (0.68%) 
Immune system disorders     
Contrast media allergy  1  1/444 (0.23%)  0/444 (0.00%) 
Infections and infestations     
Acute bronchitis  1  1/444 (0.23%)  0/444 (0.00%) 
Acute gastroenteritis  1  2/444 (0.45%)  0/444 (0.00%) 
Acute pyelonephritis  1  2/444 (0.45%)  0/444 (0.00%) 
Biliary tract infection  1  1/444 (0.23%)  3/444 (0.68%) 
Bronchopneumonia  1  1/444 (0.23%)  0/444 (0.00%) 
Cellulitis of foot  1  1/444 (0.23%)  0/444 (0.00%) 
Cryptococcal pneumonitis  1  1/444 (0.23%)  0/444 (0.00%) 
Cystitis  1  1/444 (0.23%)  0/444 (0.00%) 
Enteritis infectious  1  1/444 (0.23%)  0/444 (0.00%) 
Hepatic infection bacterial  1  1/444 (0.23%)  0/444 (0.00%) 
Herpes zoster  1  1/444 (0.23%)  2/444 (0.45%) 
Infectious colitis  1  1/444 (0.23%)  1/444 (0.23%) 
Intra-abdominal infection  1  3/444 (0.68%)  0/444 (0.00%) 
Liver abscess  1  34/444 (7.66%)  3/444 (0.68%) 
Otitis media chronic  1  1/444 (0.23%)  0/444 (0.00%) 
Periodontal abscess  1  2/444 (0.45%)  0/444 (0.00%) 
Pneumonia  1  5/444 (1.13%)  1/444 (0.23%) 
Pulpitis  1  1/444 (0.23%)  0/444 (0.00%) 
Rectal abscess  1  1/444 (0.23%)  0/444 (0.00%) 
Sepsis  1  6/444 (1.35%)  4/444 (0.90%) 
Spontaneous bacterial peritonitis  1  5/444 (1.13%)  0/444 (0.00%) 
Tuberculous pleurisy  1  1/444 (0.23%)  1/444 (0.23%) 
UTI  1  1/444 (0.23%)  0/444 (0.00%) 
Upper respiratory infection  1  1/444 (0.23%)  0/444 (0.00%) 
Urinary tract infection  1  1/444 (0.23%)  2/444 (0.45%) 
Pyelonephritis  1  0/444 (0.00%)  1/444 (0.23%) 
Injury, poisoning and procedural complications     
Compression fracture  1  1/444 (0.23%)  0/444 (0.00%) 
Fall  1  1/444 (0.23%)  1/444 (0.23%) 
Fracture of lateral malleolus, closed  1  2/444 (0.45%)  3/444 (0.68%) 
Humerus fracture  1  1/444 (0.23%)  1/444 (0.23%) 
Maternal exposure during pregnancy  1  1/444 (0.23%)  0/444 (0.00%) 
Nerve injury  1  1/444 (0.23%)  0/444 (0.00%) 
Operative haemorrhage  1  1/444 (0.23%)  0/444 (0.00%) 
Polytraumatism  1  1/444 (0.23%)  0/444 (0.00%) 
Post embolization syndrome  1  1/444 (0.23%)  0/444 (0.00%) 
Post procedural bile leak  1  3/444 (0.68%)  0/444 (0.00%) 
Ankle fracture  1  0/444 (0.00%)  1/444 (0.23%) 
Femoral neck fracture  1  0/444 (0.00%)  2/444 (0.45%) 
Traffic accident  1  0/444 (0.00%)  1/444 (0.23%) 
Investigations     
ALT increased  1  3/444 (0.68%)  1/444 (0.23%) 
AST increased  1  3/444 (0.68%)  1/444 (0.23%) 
Blood bilirubin increased  1  1/444 (0.23%)  2/444 (0.45%) 
CRP increased  1  2/444 (0.45%)  0/444 (0.00%) 
Creatinine increased  1  2/444 (0.45%)  1/444 (0.23%) 
Elevated liver enzymes  1  1/444 (0.23%)  0/444 (0.00%) 
Liver biopsy  1  1/444 (0.23%)  0/444 (0.00%) 
Spleen scan abnormal  1  1/444 (0.23%)  0/444 (0.00%) 
Platelet count decreased  1  0/444 (0.00%)  1/444 (0.23%) 
WBC decreased  1  0/444 (0.00%)  1/444 (0.23%) 
Hypokalaemia  1  2/444 (0.45%)  1/444 (0.23%) 
Metabolism and nutrition disorders     
Anorexia  1  2/444 (0.45%)  1/444 (0.23%) 
Diabetes mellitus aggravated  1  1/444 (0.23%)  2/444 (0.45%) 
Electrolyte imbalance  1  1/444 (0.23%)  0/444 (0.00%) 
Gout aggravated  1  1/444 (0.23%)  0/444 (0.00%) 
Hypercalcaemia  1  1/444 (0.23%)  1/444 (0.23%) 
Hyperglycemia  1  1/444 (0.23%)  4/444 (0.90%) 
Hyperkalemia  1  2/444 (0.45%)  0/444 (0.00%) 
Hypoglycaemia  1  2/444 (0.45%)  0/444 (0.00%) 
Inappetence  1  2/444 (0.45%)  0/444 (0.00%) 
Inappetence  1  1/444 (0.23%)  1/444 (0.23%) 
Tumor lysis syndrome  1  1/444 (0.23%)  0/444 (0.00%) 
Hyponatremia  1  0/444 (0.00%)  2/444 (0.45%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  2/444 (0.45%)  0/444 (0.00%) 
Back pain  1  2/444 (0.45%)  2/444 (0.45%) 
Cervical disc herniation  1  1/444 (0.23%)  0/444 (0.00%) 
Pain in thigh  1  1/444 (0.23%)  0/444 (0.00%) 
Pseudogout  1  1/444 (0.23%)  0/444 (0.00%) 
Rhabdomyolysis  1  1/444 (0.23%)  0/444 (0.00%) 
Spinal column stenosis  1  3/444 (0.68%)  1/444 (0.23%) 
Wrist pain  1  1/444 (0.23%)  0/444 (0.00%) 
Avascular necrosis femoral head  1  0/444 (0.00%)  1/444 (0.23%) 
Spondylitis  1  0/444 (0.00%)  1/444 (0.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/444 (0.23%)  0/444 (0.00%) 
Bone metastases  1  8/444 (1.80%)  3/444 (0.68%) 
Brain metastases  1  1/444 (0.23%)  0/444 (0.00%) 
Cancer of descending colon  1  1/444 (0.23%)  0/444 (0.00%) 
Gastric cancer  1  2/444 (0.45%)  2/444 (0.45%) 
Hemangioma  1  1/444 (0.23%)  0/444 (0.00%) 
Hepatocellular carcinoma non-resectable  1  1/444 (0.23%)  5/444 (1.13%) 
Hepatoma recurrent  1  1/444 (0.23%)  0/444 (0.00%) 
Liver carcinoma ruptured  1  2/444 (0.45%)  6/444 (1.35%) 
Lung metastases  1  2/444 (0.45%)  0/444 (0.00%) 
Pancreatic carcinoma  1  1/444 (0.23%)  0/444 (0.00%) 
Spinal metastases  1  1/444 (0.23%)  0/444 (0.00%) 
Tumor necrosis  1  2/444 (0.45%)  0/444 (0.00%) 
Tumor rupture  1  1/444 (0.23%)  0/444 (0.00%) 
Adenocarcinoma of the gastrooesophageal junction  1  0/444 (0.00%)  1/444 (0.23%) 
Benign neoplasm of spinal cord  1  0/444 (0.00%)  1/444 (0.23%) 
Bladder cancer  1  0/444 (0.00%)  4/444 (0.90%) 
Cecal cancer  1  0/444 (0.00%)  1/444 (0.23%) 
Inverting papilloma of the nasal cavity  1  0/444 (0.00%)  1/444 (0.23%) 
Malignant neoplasm of cheek mucosa  1  0/444 (0.00%)  2/444 (0.45%) 
Oesophageal carcinoma  1  0/444 (0.00%)  1/444 (0.23%) 
Rectal cancer  1  0/444 (0.00%)  1/444 (0.23%) 
Schwannoma  1  0/444 (0.00%)  1/444 (0.23%) 
Tumour embolism  1  0/444 (0.00%)  1/444 (0.23%) 
Nervous system disorders     
Cerebral infarction  1  5/444 (1.13%)  5/444 (1.13%) 
Hepatic encephalopathy  1  12/444 (2.70%)  6/444 (1.35%) 
Intracranial hemorrhage  1  3/444 (0.68%)  1/444 (0.23%) 
Numbness of lower extremities  1  1/444 (0.23%)  0/444 (0.00%) 
Spinal cord compression  1  1/444 (0.23%)  0/444 (0.00%) 
Syncope  1  1/444 (0.23%)  0/444 (0.00%) 
Dizziness  1  0/444 (0.00%)  1/444 (0.23%) 
Psychiatric disorders     
Delirium  1  1/444 (0.23%)  0/444 (0.00%) 
Orientation disturbed  1  1/444 (0.23%)  0/444 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  4/444 (0.90%)  3/444 (0.68%) 
Renal failure  1  4/444 (0.90%)  4/444 (0.90%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/444 (0.00%)  1/444 (0.23%) 
Respiratory, thoracic and mediastinal disorders     
Asphyxia  1  1/444 (0.23%)  0/444 (0.00%) 
Aspiration pneumonitis  1  2/444 (0.45%)  0/444 (0.00%) 
Bronchiectasis  1  1/444 (0.23%)  0/444 (0.00%) 
COPD exacerbation  1  1/444 (0.23%)  0/444 (0.00%) 
Chronic cough  1  2/444 (0.45%)  1/444 (0.23%) 
Dyspnea  1  2/444 (0.45%)  0/444 (0.00%) 
Pleural effusion  1  7/444 (1.58%)  2/444 (0.45%) 
Pneumonitis  1  1/444 (0.23%)  0/444 (0.00%) 
Pulmonary embolism  1  1/444 (0.23%)  1/444 (0.23%) 
Respiratory failure  1  1/444 (0.23%)  0/444 (0.00%) 
Shortness of breath  1  1/444 (0.23%)  0/444 (0.00%) 
Asthma  1  0/444 (0.00%)  1/444 (0.23%) 
Atelectasis  1  0/444 (0.00%)  1/444 (0.23%) 
Skin and subcutaneous tissue disorders     
Eczema nummular  1  1/444 (0.23%)  0/444 (0.00%) 
Stevens-Johnson syndrome  1  0/444 (0.00%)  1/444 (0.23%) 
Surgical and medical procedures     
Gastrooesophageal variceal haemorrhage prophylaxis  1  3/444 (0.68%)  0/444 (0.00%) 
Induced abortion  1  1/444 (0.23%)  0/444 (0.00%) 
Oesophageal variceal ligation  1  3/444 (0.68%)  5/444 (1.13%) 
Vascular disorders     
Varicose vein ruptured  1  1/444 (0.23%)  0/444 (0.00%) 
Abdominal aortic aneurysm  1  0/444 (0.00%)  1/444 (0.23%) 
Arterial stenosis  1  0/444 (0.00%)  1/444 (0.23%) 
Deep vein thrombosis  1  0/444 (0.00%)  1/444 (0.23%) 
Obstructive arteriosclerosis of lower extremities  1  0/444 (0.00%)  1/444 (0.23%) 
Vascular disorder  1  0/444 (0.00%)  1/444 (0.23%) 
1
Term from vocabulary, CTCAE, version 4.02
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Orantinib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   443/444 (99.77%)   436/444 (98.20%) 
Blood and lymphatic system disorders     
Anaemia  1  54/444 (12.16%)  32/444 (7.21%) 
Gastrointestinal disorders     
Abdominal distension  1  50/444 (11.26%)  53/444 (11.94%) 
Abdominal pain  1  317/444 (71.40%)  292/444 (65.77%) 
Abdominal pain upper  1  56/444 (12.61%)  46/444 (10.36%) 
Ascites  1  140/444 (31.53%)  73/444 (16.44%) 
Constipation  1  179/444 (40.32%)  147/444 (33.11%) 
Diarrhoea  1  123/444 (27.70%)  70/444 (15.77%) 
Dyspepsia  1  51/444 (11.49%)  47/444 (10.59%) 
Gastritis  1  23/444 (5.18%)  29/444 (6.53%) 
Gastrointestinal pain  1  22/444 (4.95%)  14/444 (3.15%) 
Nausea  1  179/444 (40.32%)  179/444 (40.32%) 
Vomiting  1  126/444 (28.38%)  116/444 (26.13%) 
General disorders     
Chills  1  34/444 (7.66%)  23/444 (5.18%) 
Face oedema  1  138/444 (31.08%)  8/444 (1.80%) 
Fatigue  1  101/444 (22.75%)  92/444 (20.72%) 
Malaise  1  101/444 (22.75%)  86/444 (19.37%) 
Non-cardiac chest pain  1  32/444 (7.21%)  25/444 (5.63%) 
Oedema peripheral  1  130/444 (29.28%)  59/444 (13.29%) 
Pyrexia  1  264/444 (59.46%)  284/444 (63.96%) 
Hepatobiliary disorders     
Hepatic failure  1  24/444 (5.41%)  20/444 (4.50%) 
Infections and infestations     
Liver abscess  1  30/444 (6.76%)  3/444 (0.68%) 
Upper respiratory tract infection  1  86/444 (19.37%)  85/444 (19.14%) 
Investigations     
ALT increased  1  200/444 (45.05%)  170/444 (38.29%) 
AST increased  1  223/444 (50.23%)  189/444 (42.57%) 
ALP increased  1  64/444 (14.41%)  22/444 (4.95%) 
Bilirubin increased  1  77/444 (17.34%)  75/444 (16.89%) 
CRP increased  1  47/444 (10.59%)  44/444 (9.91%) 
Lymphocyte count decreased  1  40/444 (9.01%)  45/444 (10.14%) 
Platelet count decreased  1  53/444 (11.94%)  48/444 (10.81%) 
Weight decreased  1  31/444 (6.98%)  20/444 (4.50%) 
Metabolism and nutrition disorders     
Decreased appetite  1  209/444 (47.07%)  149/444 (33.56%) 
Hyperkalaemia  1  23/444 (5.18%)  14/444 (3.15%) 
Hypoalbuminaemia  1  98/444 (22.07%)  85/444 (19.14%) 
Hypokalaemia  1  34/444 (7.66%)  16/444 (3.60%) 
Hyponatraemia  1  31/444 (6.98%)  22/444 (4.95%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  34/444 (7.66%)  19/444 (4.28%) 
Back pain  1  90/444 (20.27%)  94/444 (21.17%) 
Musculoskeletal pain  1  38/444 (8.56%)  36/444 (8.11%) 
Myalgia  1  32/444 (7.21%)  22/444 (4.95%) 
Pain in extremity  1  40/444 (9.01%)  30/444 (6.76%) 
Nervous system disorders     
Dizziness  1  38/444 (8.56%)  35/444 (7.88%) 
Headache  1  74/444 (16.67%)  62/444 (13.96%) 
Psychiatric disorders     
Insomnia  1  79/444 (17.79%)  68/444 (15.32%) 
Renal and urinary disorders     
Chromaturia  1  103/444 (23.20%)  18/444 (4.05%) 
Proteinuria  1  47/444 (10.59%)  17/444 (3.83%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  69/444 (15.54%)  68/444 (15.32%) 
Dyspnoea  1  29/444 (6.53%)  30/444 (6.76%) 
Pleural effusion  1  36/444 (8.11%)  16/444 (3.60%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  43/444 (9.68%)  51/444 (11.49%) 
Vascular disorders     
Hypertension  1  59/444 (13.29%)  57/444 (12.84%) 
1
Term from vocabulary, CTCAE, version 4.02
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Taiho Pharmaceutical Co., Ltd.
Organization: Clinical Trial Registration Contact
EMail: toiawase@taiho.co.jp
Layout table for additonal information
Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01465464    
Other Study ID Numbers: Taiho132150
First Submitted: November 1, 2011
First Posted: November 4, 2011
Results First Submitted: November 4, 2018
Results First Posted: August 7, 2019
Last Update Posted: August 7, 2019