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Efficacy Multicentre Trial of ImmunoTherapy Vaccination With Abagovomab to Treat Ovarian Cancer Patients (MIMOSA)

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ClinicalTrials.gov Identifier: NCT00418574
Recruitment Status : Terminated (No benefit on primary end point (RFS); no rationale to collect survival data)
First Posted : January 5, 2007
Results First Posted : November 18, 2011
Last Update Posted : November 24, 2011
Sponsor:
Information provided by (Responsible Party):
Menarini Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Ovarian Cancer
Interventions Biological: Abagovomab
Biological: Placebo
Enrollment 888
Recruitment Details

Study population was recruited in 139 sites (Hospitals/University Clinics) distributed in Europe (Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland and Spain) and US.

Date of first patient randomised: 08 December 2006 Date of last patient randomised: 26 December 2008

Pre-assignment Details  
Arm/Group Title Abagovomab Placebo
Hide Arm/Group Description 2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase) 2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
Period Title: Overall Study
Started 593 295
TREATED 592 294
Completed 545 272
Not Completed 48 23
Arm/Group Title Abagovomab Placebo Total
Hide Arm/Group Description 2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase) 2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase) Total of all reporting groups
Overall Number of Baseline Participants 593 295 888
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 593 participants 295 participants 888 participants
<=18 years
1
   0.2%
0
   0.0%
1
   0.1%
Between 18 and 65 years
447
  75.4%
227
  76.9%
674
  75.9%
>=65 years
145
  24.5%
68
  23.1%
213
  24.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 593 participants 295 participants 888 participants
56.4  (10.57) 56.0  (10.47) 56.3  (10.53)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 593 participants 295 participants 888 participants
593 295 888
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 593 participants 295 participants 888 participants
France 1 2 3
United States 91 47 138
Hungary 17 8 25
Czech Republic 54 28 82
Poland 53 25 78
Spain 55 48 103
Belgium 19 4 23
Germany 206 93 299
Italy 97 40 137
Histology of ovarian tumor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 593 participants 295 participants 888 participants
Serous/papillary 481 245 726
Endometrioid 38 21 59
Mucinous 6 3 9
Undifferentiated 14 7 21
Mixed tumor 18 7 25
Others 33 12 45
missing 3 0 3
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 593 participants 295 participants 888 participants
0 460 240 700
1 131 55 186
2 2 0 2
[1]
Measure Description: This scale and criteria are used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The scale runs from the score 0 to 5, with 0 denoting the status "Fully active, able to carry on all pre-disease performance without restriction" and 5 the status "Dead".
Grade of histologic differentiation   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 593 participants 295 participants 888 participants
G1-G2 160 82 242
G3-G4 365 185 550
GX 12 4 16
not done 56 24 80
[1]
Measure Description:

Histologic grade, also called differentiation, refers to how much the tumor cells resemble normal cells of the same tissue type.

GX Grade cannot be assessed (Undetermined grade) G1 Well-differentiated (Low grade) - best prognosis G2 Moderately differentiated (Intermediate grade) G3 Poorly differentiated (High grade) G4 Undifferentiated (High grade) - worst prognosis

International Federation of Gynecology and Obstetrics (FIGO) stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 593 participants 295 participants 888 participants
III 513 252 765
IV 80 42 122
missing 0 1 1
[1]
Measure Description: International system of staging which identifies the spread of the ovarian cancer at the point of diagnosis [STAGE 1 - Tumour is confined to the ovary / ovaries; STAGE 2 – Tumour involves one or both ovaries and has extended into the pelvis; STAGE 3 – The tumour involves one or both ovaries with microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node metastasis, includes liver capsule metastasis; STAGE: 4 – Distant metastasis beyond the peritoneal cavity, liver parenchymal metastasis.]
Tumor size after debulking surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 593 participants 295 participants 888 participants
<= 1 cm 479 232 711
> 1 cm 114 63 177
Serum CA-125 after 3rd chemotherapy cycle  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 593 participants 295 participants 888 participants
<= 35 U/ml 479 239 718
> 35 U/ml 114 55 169
missing 0 1 1
1.Primary Outcome
Title Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC)
Hide Description The Recurrence free survival correspond to the time from date of randomization to documented disease recurrence or death. Disease recurrence is defined as the appearance of any lesion or development of tumor-related symptoms evaluated by medical examination and must be confirmed by a documented CT scan.
Time Frame Every 12 weeks up to recurrence or up to 3 months after last administered dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT) population (i.e. all randomized patients)
Arm/Group Title Abagovomab Placebo
Hide Arm/Group Description:
2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
Overall Number of Participants Analyzed 593 295
Median (95% Confidence Interval)
Unit of Measure: days
403
(323 to 414)
402
(323 to 487)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abagovomab, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.301
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.099
Confidence Interval (2-Sided) 95%
0.919 to 1.315
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival
Hide Description 2 years survival rate
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT) population (i.e. all randomized patients)
Arm/Group Title Abagovomab Placebo
Hide Arm/Group Description:
2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
Overall Number of Participants Analyzed 593 295
Measure Type: Number
Unit of Measure: Percentage of participants
80 79
3.Secondary Outcome
Title Safety
Hide Description

Safety was analyzed in all patients who received at least 1 dose administration.

Adverse event (AE) are defined as events which started on or after the first dose of study medication and on or before the date of the final study visit, or within 12 weeks of the last dose if the final study visit was not performed.

Time Frame Along treatment administration and up to double blind observation period. i.e. for each patient after the first dose administration till the f inal study visit, or within 12 weeks of the last dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population (i.e. All randomized patients who received at least one dose treatment administration)
Arm/Group Title Abagovomab Placebo
Hide Arm/Group Description:
2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
Overall Number of Participants Analyzed 592 294
Measure Type: Number
Unit of Measure: participants
Patients with at least 1 Adverse Event (AE) 564 278
Patients with at least 1 Adverse Drug Reaction ADR 507 246
Patients with at least 1 Serious Adverse Event SAE 141 72
Patients with at least 1 Serious ADR (SADR) 10 3
Patients with at least 1 AE leading to withdrawal 93 57
Patients with at least 1 AE resulted in death 8 4
4.Secondary Outcome
Title Time Course of Immunoresponse
Hide Description Time course of immunologic parameters (anti-anti-idiotypic antibody - Ab3) will be assessed in all patients, by comparing levels at baseline (week 0), at week 10 after first dose administration and at end of treatment (at week 4 or week 12 after the last administered dose, as appropriate).
Time Frame at baseline, at week 10 after first dose administration and at final study visit (at week 4 or week 12 after the last administered dose, as appropriate)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received abagovomab (evaluable population)and have baseline serum sample: 576 at baseline; 538 at week 10 after first dose intake; 449 at the final study visit
Arm/Group Title Abagovomab
Hide Arm/Group Description:
2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
Overall Number of Participants Analyzed 576
Median (Full Range)
Unit of Measure: ng/ml
Ab3 (baseline)
0
(0 to 118000)
Ab3 (week 10)
63550
(0 to 777000)
Ab3 (end of treatment)
493000
(0 to 2720000)
Time Frame 4 years
Adverse Event Reporting Description Adverse Events monitored throughout the observation period, at each visit prior dosing (every 2 weeks during the induction phase, every 4 weeks during the maintenance phase)
 
Arm/Group Title Abagovomab Placebo
Hide Arm/Group Description 2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase) 2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
All-Cause Mortality
Abagovomab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Abagovomab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   141/592 (23.82%)      72/294 (24.49%)    
Blood and lymphatic system disorders     
Anaemias NEC  1  2/592 (0.34%)  2 1/294 (0.34%)  1
Lymphatic system disorders NEC  1  2/592 (0.34%)  2 1/294 (0.34%)  1
Thrombocytopenias  1  1/592 (0.17%)  6 0/294 (0.00%)  0
Cardiac disorders     
Ischaemic coronary artery disorders  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Pericardial disorders NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Supraventricular arrhythmias  1  1/592 (0.17%)  2 0/294 (0.00%)  0
Ear and labyrinth disorders     
Inner ear signs and symptoms  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Tympanic membrane disorders (excl infections)  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Endocrine disorders     
Thyroid disorders NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Thyroid hyperfunction disorders  1  0/592 (0.00%)  0 1/294 (0.34%)  2
Eye disorders     
Glaucomas (excl congenital)  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Retinal structural change, deposit and degeneration  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Gastrointestinal disorders     
Abdominal findings abnormal  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Abdominal hernias, site unspecified  1  1/592 (0.17%)  1 4/294 (1.36%)  4
Acute and chronic pancreatitis  1  2/592 (0.34%)  3 0/294 (0.00%)  0
Diarrhoea (excl infective)  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Duodenal and small intestinal stenosis and obstruction  1  3/592 (0.51%)  3 0/294 (0.00%)  0
Dyspeptic signs and symptoms  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Gastric and oesophageal haemorrhages  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Gastritis (excl infective)  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Gastrointestinal and abdominal pains (excl oral and throat)  1  11/592 (1.86%)  13 4/294 (1.36%)  4
Gastrointestinal atonic and hypomotility disorders NEC  1  3/592 (0.51%)  3 1/294 (0.34%)  1
Gastrointestinal inflammatory disorders NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Gastrointestinal necrosis and gangrene (excl gangrenous hernia)  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Gastrointestinal stenosis and obstruction NEC  1  14/592 (2.36%)  15 12/294 (4.08%)  17
Large intestinal stenosis and obstruction  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Nausea and vomiting symptoms  1  3/592 (0.51%)  5 4/294 (1.36%)  5
Non-site specific gastrointestinal haemorrhages  1  2/592 (0.34%)  2 1/294 (0.34%)  1
Peritoneal and retroperitoneal disorders  1  18/592 (3.04%)  22 6/294 (2.04%)  6
Peritoneal and retroperitoneal fibrosis and adhesions  1  1/592 (0.17%)  1 0/294 (0.00%)  0
General disorders     
Device issues NEC  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Febrile disorders  1  3/592 (0.51%)  3 2/294 (0.68%)  3
General signs and symptoms NEC  1  3/592 (0.51%)  3 0/294 (0.00%)  0
Hernias NEC  1  2/592 (0.34%)  2 2/294 (0.68%)  2
Injection site reactions  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Oedema NEC  1  2/592 (0.34%)  2 0/294 (0.00%)  0
Pain and discomfort NEC  1  2/592 (0.34%)  2 1/294 (0.34%)  1
Therapeutic and nontherapeutic responses  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis and cholelithiasis  1  1/592 (0.17%)  1 1/294 (0.34%)  1
Cholestasis and jaundice  1  1/592 (0.17%)  1 1/294 (0.34%)  2
Gallbladder disorders NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Immune system disorders     
Allergic conditions NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Infections and infestations     
Abdominal and gastrointestinal infections  1  2/592 (0.34%)  2 2/294 (0.68%)  2
Aspergillus infections  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Bacterial infections NEC  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Dental and oral soft tissue infections  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Ear infections  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Herpes viral infections  1  0/592 (0.00%)  0 2/294 (0.68%)  2
Influenza viral infections  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Lower respiratory tract and lung infections  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Sepsis, bacteraemia, viraemia and fungaemia NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Streptococcal infections  1  1/592 (0.17%)  1 3/294 (1.02%)  4
Upper respiratory tract infections  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Urinary tract infections  1  3/592 (0.51%)  3 0/294 (0.00%)  0
Vascular infections  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Injury, poisoning and procedural complications     
Abdominal injuries NEC  1  2/592 (0.34%)  2 0/294 (0.00%)  0
Lower limb fractures and dislocations  1  2/592 (0.34%)  2 1/294 (0.34%)  1
Non-site specific injuries NEC  1  3/592 (0.51%)  3 1/294 (0.34%)  1
Non-site specific procedural complications  1  7/592 (1.18%)  8 0/294 (0.00%)  0
Pelvic fractures and dislocations  1  0/592 (0.00%)  0 1/294 (0.34%)  2
Spinal fractures and dislocations  1  0/592 (0.00%)  0 2/294 (0.68%)  2
Upper limb fractures and dislocations  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Investigations     
Digestive enzymes  1  1/592 (0.17%)  2 0/294 (0.00%)  0
Liver function analyses  1  3/592 (0.51%)  5 0/294 (0.00%)  0
Renal function analyses  1  2/592 (0.34%)  2 0/294 (0.00%)  0
Skeletal and cardiac muscle analyses  1  1/592 (0.17%)  2 0/294 (0.00%)  0
Tissue enzyme analyses NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Metabolism and nutrition disorders     
Appetite disorders  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Diabetes mellitus (incl subtypes)  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Musculoskeletal and connective tissue disorders     
Bone related signs and symptoms  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Intervertebral disc disorders NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Joint related signs and symptoms  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Metabolic bone disorders  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Musculoskeletal and connective tissue pain and discomfort  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Osteoarthropathies  1  1/592 (0.17%)  1 1/294 (0.34%)  1
Soft tissue disorders NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Spine and neck deformities  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bone neoplasms benign (excl cysts)  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Endocrine neoplasms malignant and unspecified NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Gastrointestinal neoplasms malignant NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Metastases to specified sites  1  14/592 (2.36%)  16 13/294 (4.42%)  13
Neoplasms malignant site unspecified NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Neoplasms unspecified malignancy and site unspecified NEC  1  2/592 (0.34%)  3 1/294 (0.34%)  1
Nervous system neoplasms unspecified malignancy NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Non-small cell neoplasms malignant of the respiratory tract cell type specified  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Oncologic complications and emergencies  1  1/592 (0.17%)  1 1/294 (0.34%)  1
Ovarian neoplasms malignant (excl germ cell)  1  61/592 (10.30%)  80 41/294 (13.95%)  46
Rectal neoplasms malignant  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Skin neoplasms malignant and unspecified (excl melanoma)  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Vaginal neoplasms malignant  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Nervous system disorders     
Central nervous system haemorrhages and cerebrovascular accidents  1  3/592 (0.51%)  3 1/294 (0.34%)  1
Disturbances in consciousness NEC  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Neurological signs and symptoms NEC  1  2/592 (0.34%)  2 1/294 (0.34%)  1
Peripheral neuropathies NEC  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Seizures and seizure disorders NEC  1  2/592 (0.34%)  2 0/294 (0.00%)  0
Speech and language abnormalities  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Transient cerebrovascular events  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Psychiatric disorders     
Anxiety symptoms  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Depressive disorders  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Renal and urinary disorders     
Renal failure and impairment  1  2/592 (0.34%)  2 0/294 (0.00%)  0
Renal obstructive disorders  1  2/592 (0.34%)  2 0/294 (0.00%)  0
Ureteric disorders NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Reproductive system and breast disorders     
Breast disorders NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Pelvic prolapse conditions  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Uterine disorders NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Breathing abnormalities  1  3/592 (0.51%)  3 0/294 (0.00%)  0
Pneumothorax and pleural effusions NEC  1  7/592 (1.18%)  9 5/294 (1.70%)  5
Pulmonary thrombotic and embolic conditions  1  3/592 (0.51%)  3 0/294 (0.00%)  0
Skin and subcutaneous tissue disorders     
Connective tissue disorders  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Dermal and epidermal conditions NEC  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Dermatitis and eczema  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Vascular disorders     
Accelerated and malignant hypertension  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Aortic embolism and thrombosis  1  1/592 (0.17%)  1 0/294 (0.00%)  0
Lymphangiopathies  1  3/592 (0.51%)  6 0/294 (0.00%)  0
Lymphoedemas  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Non-site specific embolism and thrombosis  1  2/592 (0.34%)  2 0/294 (0.00%)  0
Peripheral embolism and thrombosis  1  0/592 (0.00%)  0 1/294 (0.34%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abagovomab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   532/592 (89.86%)      261/294 (88.78%)    
Gastrointestinal disorders     
Diarrhoea (excl infective)  1  98/592 (16.55%)  177 41/294 (13.95%)  64
Flatulence, bloating and distension  1  45/592 (7.60%)  69 25/294 (8.50%)  33
Gastrointestinal and abdominal pains (excl oral and throat)  1  183/592 (30.91%)  300 81/294 (27.55%)  125
Gastrointestinal atonic and hypomotility disorders NEC  1  82/592 (13.85%)  115 38/294 (12.93%)  54
Nausea and vomiting symptoms  1  130/592 (21.96%)  325 64/294 (21.77%)  138
General disorders     
Asthenic conditions  1  191/592 (32.26%)  431 89/294 (30.27%)  240
Febrile disorders  1  67/592 (11.32%)  111 40/294 (13.61%)  73
Feelings and sensations NEC  1  34/592 (5.74%)  42 14/294 (4.76%)  25
General signs and symptoms NEC  1  44/592 (7.43%)  75 19/294 (6.46%)  25
Injection site reactions  1  467/592 (78.89%)  4906 222/294 (75.51%)  2352
Oedema NEC  1  61/592 (10.30%)  82 32/294 (10.88%)  39
Pain and discomfort NEC  1  37/592 (6.25%)  44 20/294 (6.80%)  22
Infections and infestations     
Lower respiratory tract and lung infections  1  43/592 (7.26%)  49 8/294 (2.72%)  8
Upper respiratory tract infections  1  142/592 (23.99%)  242 70/294 (23.81%)  124
Urinary tract infections  1  80/592 (13.51%)  114 27/294 (9.18%)  33
Investigations     
Physical examination procedures  1  33/592 (5.57%)  46 20/294 (6.80%)  33
Musculoskeletal and connective tissue disorders     
Bone related signs and symptoms  1  41/592 (6.93%)  59 26/294 (8.84%)  44
Joint related signs and symptoms  1  134/592 (22.64%)  263 67/294 (22.79%)  112
Muscle pains  1  59/592 (9.97%)  104 35/294 (11.90%)  59
Musculoskeletal and connective tissue pain and discomfort  1  171/592 (28.89%)  355 79/294 (26.87%)  212
Nervous system disorders     
Headaches NEC  1  83/592 (14.02%)  227 38/294 (12.93%)  86
Neurological signs and symptoms NEC  1  42/592 (7.09%)  63 25/294 (8.50%)  30
Peripheral neuropathies NEC  1  46/592 (7.77%)  57 25/294 (8.50%)  28
Psychiatric disorders     
Disturbances in initiating and maintaining sleep  1  31/592 (5.24%)  37 17/294 (5.78%)  24
Renal and urinary disorders     
Bladder and urethral symptoms  1  38/592 (6.42%)  47 25/294 (8.50%)  30
Respiratory, thoracic and mediastinal disorders     
Breathing abnormalities  1  48/592 (8.11%)  59 23/294 (7.82%)  26
Coughing and associated symptoms  1  43/592 (7.26%)  51 25/294 (8.50%)  31
Skin and subcutaneous tissue disorders     
Erythemas  1  40/592 (6.76%)  76 22/294 (7.48%)  37
Pruritus NEC  1  30/592 (5.07%)  50 15/294 (5.10%)  16
Rashes, eruptions and exanthems NEC  1  33/592 (5.57%)  47 19/294 (6.46%)  23
Vascular disorders     
Peripheral vascular disorders NEC  1  49/592 (8.28%)  62 26/294 (8.84%)  35
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
The only disclosure restriction on the PI is that result communications shall be exchanged and discussed with the sponsor 60 days prior to submission for publication or presentation.
Results Point of Contact
Name/Title: Clinical Research Director
Organization: Menarini Ricerche SpA
Publications:
Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT00418574     History of Changes
Other Study ID Numbers: ABA-01
AGO-OVAR 10 ( Other Identifier: AGO )
2006-002801-30 ( EudraCT Number )
First Submitted: January 4, 2007
First Posted: January 5, 2007
Results First Submitted: July 1, 2011
Results First Posted: November 18, 2011
Last Update Posted: November 24, 2011