Trial Outcomes & Findings for Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer (NCT NCT03425656)
NCT ID: NCT03425656
Last Updated: 2024-06-28
Results Overview
the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
108 participants
Primary outcome timeframe
week 23
Results posted on
2024-06-28
Participant Flow
Participant milestones
| Measure |
Trastuzumab (AryoTrust)
Trastuzumab (AryoTrust) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
Trastuzumab (Herceptin)
Trastuzumab (Herceptin) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
54
|
|
Overall Study
COMPLETED
|
48
|
44
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Trastuzumab (AryoTrust)
n=54 Participants
Trastuzumab (AryoTrust) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
Trastuzumab (Herceptin)
n=54 Participants
Trastuzumab (Herceptin) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 year
n=54 Participants
|
46 year
n=54 Participants
|
46 year
n=108 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=54 Participants
|
54 Participants
n=54 Participants
|
108 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=108 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
weight
|
70 Kg
n=54 Participants
|
70 Kg
n=54 Participants
|
70 Kg
n=108 Participants
|
|
Tumor Size
|
33 mm
n=54 Participants
|
33 mm
n=54 Participants
|
33 mm
n=108 Participants
|
|
IHC 2+
|
9 participants
n=54 Participants
|
11 participants
n=54 Participants
|
20 participants
n=108 Participants
|
|
IHC 3+
|
45 Participants
n=54 Participants
|
43 Participants
n=54 Participants
|
88 Participants
n=108 Participants
|
|
FISH+
|
3 Participants
n=54 Participants
|
2 Participants
n=54 Participants
|
5 Participants
n=108 Participants
|
|
CISH+
|
6 Participants
n=54 Participants
|
9 Participants
n=54 Participants
|
15 Participants
n=108 Participants
|
|
ER and/or PR positive
|
36 Participants
n=54 Participants
|
30 Participants
n=54 Participants
|
66 Participants
n=108 Participants
|
|
ER and PR negative
|
18 Participants
n=54 Participants
|
24 Participants
n=54 Participants
|
42 Participants
n=108 Participants
|
PRIMARY outcome
Timeframe: week 23the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes
Outcome measures
| Measure |
Trastuzumab (AryoTrust)
n=48 Participants
Trastuzumab (AryoTrust) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
Trastuzumab (Herceptin)
n=44 Participants
Trastuzumab (Herceptin) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
|---|---|---|
|
Pathologic Complete Response
|
18 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: week 21clinical Complete Response + clinical Partial Response
Outcome measures
| Measure |
Trastuzumab (AryoTrust)
n=54 Participants
Trastuzumab (AryoTrust) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
Trastuzumab (Herceptin)
n=54 Participants
Trastuzumab (Herceptin) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
|---|---|---|
|
Clinical Objective Response
|
41 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: week 23Patients who underwent lumpectomy
Outcome measures
| Measure |
Trastuzumab (AryoTrust)
n=54 Participants
Trastuzumab (AryoTrust) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
Trastuzumab (Herceptin)
n=54 Participants
Trastuzumab (Herceptin) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
|---|---|---|
|
Breast Conservation Rate
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: up to week 26Population: A total of 108 patients were analyzed for AEs.Reports were based on the Safety set. The safety set included all randomized patients who received at least one dose of the study drug.
Safety assessment, including the incidence of all reported AEs and abnormal laboratory results was done. All AEs were classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs was assessed according to International Council for Harmonization (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.
Outcome measures
| Measure |
Trastuzumab (AryoTrust)
n=54 Participants
Trastuzumab (AryoTrust) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
Trastuzumab (Herceptin)
n=54 Participants
Trastuzumab (Herceptin) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
|---|---|---|
|
Safety Assessment by Evaluation of Adverse Events (AEs) and Abnormal Laboratory Results
|
54 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: week 10, week 13, week 19, week 26The levels of anti-drug antibodies against Trastuzumab ( aryotrust ) are assessed via ELISA and the percantage of positive value are reported
Outcome measures
| Measure |
Trastuzumab (AryoTrust)
n=54 Participants
Trastuzumab (AryoTrust) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
Trastuzumab (Herceptin)
n=54 Participants
Trastuzumab (Herceptin) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
|---|---|---|
|
The Number of Participants With Anti-drug Antibodies Against Trastuzumab (AryoTrust)
|
0 Participants
|
0 Participants
|
Adverse Events
Trastuzumab (AryoTrust) / ACTH
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Trastuzumab (Herceptin) / ACTH
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Trastuzumab (AryoTrust) / ACTH
n=54 participants at risk
Trastuzumab (AryoTrust) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
Trastuzumab (Herceptin) / ACTH
n=54 participants at risk
Trastuzumab (Herceptin) is given concomitantly with docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide: Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Blood and lymphatic system disorders
Anaemia
|
24.1%
13/54 • Through study completion (26 weeks)
|
31.5%
17/54 • Through study completion (26 weeks)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/54 • Through study completion (26 weeks)
|
1.9%
1/54 • Through study completion (26 weeks)
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.7%
2/54 • Through study completion (26 weeks)
|
5.6%
3/54 • Through study completion (26 weeks)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
2/54 • Through study completion (26 weeks)
|
1.9%
1/54 • Through study completion (26 weeks)
|
|
Cardiac disorders
Ejection fraction decreased
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Cardiac disorders
Chest pain
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/54 • Through study completion (26 weeks)
|
1.9%
1/54 • Through study completion (26 weeks)
|
|
Eye disorders
Eye irritation
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Ageusia
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Faecal vomiting
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
2/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
General disorders
Asthenia
|
1.9%
1/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
General disorders
Axillary pain
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
General disorders
Disease Progression
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
General disorders
Fatigue
|
0.00%
0/54 • Through study completion (26 weeks)
|
1.9%
1/54 • Through study completion (26 weeks)
|
|
General disorders
Hot flush
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
General disorders
Pain
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
General disorders
Pyrexia
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
General disorders
Swelling
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/54 • Through study completion (26 weeks)
|
1.9%
1/54 • Through study completion (26 weeks)
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Infections and infestations
Nail infection
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
2/54 • Through study completion (26 weeks)
|
7.4%
4/54 • Through study completion (26 weeks)
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
2/54 • Through study completion (26 weeks)
|
3.7%
2/54 • Through study completion (26 weeks)
|
|
Investigations
Blood alkaline phosphatase increased
|
5.6%
3/54 • Through study completion (26 weeks)
|
1.9%
1/54 • Through study completion (26 weeks)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Investigations
Hyperbilirubinaemia
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Investigations
Hyperphosphataemia
|
0.00%
0/54 • Through study completion (26 weeks)
|
1.9%
1/54 • Through study completion (26 weeks)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/54 • Through study completion (26 weeks)
|
3.7%
2/54 • Through study completion (26 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Nervous system disorders
Aphasia
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Nervous system disorders
Headache
|
1.9%
1/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Nervous system disorders
Vertigo
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.9%
1/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
48.1%
26/54 • Through study completion (26 weeks)
|
81.5%
44/54 • Through study completion (26 weeks)
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.9%
1/54 • Through study completion (26 weeks)
|
1.9%
1/54 • Through study completion (26 weeks)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
3/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
3.7%
2/54 • Through study completion (26 weeks)
|
3.7%
2/54 • Through study completion (26 weeks)
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.9%
1/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Skin and subcutaneous tissue disorders
Skin wound
|
1.9%
1/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Vascular disorders
Epistaxis
|
1.9%
1/54 • Through study completion (26 weeks)
|
0.00%
0/54 • Through study completion (26 weeks)
|
|
Vascular disorders
Hypertension
|
1.9%
1/54 • Through study completion (26 weeks)
|
3.7%
2/54 • Through study completion (26 weeks)
|
Additional Information
Dr. Reza Safaei, M.D
Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Phone: 0098-9124548684
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place