Trial Outcomes & Findings for Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC) (NCT NCT01102231)

Last Updated: 2021-02-16

Results Overview

percentage of patients with disease control (complete response + partial response + stable disease) according to RECIST 1.1 criteria Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease (at least a 20% increase in the sum of diameters of target lesions).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

106 participants

Primary outcome timeframe

16 weeks after inclusion

Results posted on

2021-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	Chemoradiotherapy + Cetuximab Chemotherapy + cetuximab + radiotherapy Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week)
Overall Study STARTED	106
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemoradiotherapy + Cetuximab Chemotherapy + cetuximab + radiotherapy Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week)
Overall Study Protocol Violation	3
Overall Study Lack of Efficacy	2
Overall Study Death	2
Overall Study Adverse Event	3
Overall Study Withdrawal by Subject	1
Overall Study Did not received the treatment	4

Baseline Characteristics

Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemoradiotherapy + Cetuximab n=106 Participants Chemoradiotherapy Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week)
Age, Continuous	57.32 years n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants
Region of Enrollment France	106 participants n=5 Participants
Smoker	100 Participants n=5 Participants
Stage IIIA	53 Participants n=5 Participants
Stage IIIB	51 Participants n=5 Participants
Stage IV	2 Participants n=5 Participants
Histological subtype Sarcomatoid	2 Participants n=5 Participants
Histological subtype Adenosquamous	1 Participants n=5 Participants
Histological subtype Adenocarcinoma without bronchoalveolar component	82 Participants n=5 Participants
Histological subtype Non Small Cell	14 Participants n=5 Participants
Histological subtype Neuroendocrine carcinoma	1 Participants n=5 Participants
Histological subtype Non Squamous Non Small Cell	6 Participants n=5 Participants
ECOG Performance status PS = 0	63 Participants n=5 Participants
ECOG Performance status PS = 1	43 Participants n=5 Participants
Unresectability cause Anatomical	100 Participants n=5 Participants
Unresectability cause Functional	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks after inclusion

Population: Eligible population

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Cetuximab n=99 Participants Chemoradiotherapy Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week)
Disease-Control Rate	89 Participants

SECONDARY outcome

Timeframe: 18 months

Population: Eligible population

Percentage of patient alive 18 months after registration

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Cetuximab n=99 Participants Chemoradiotherapy Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week)
18-month Overall Survival Rate	42.4 percentage of participant Interval 32.6 to 51.9

SECONDARY outcome

Timeframe: 52.3 months (median duration of follow-up)

Progression-free survival is defined as time between date of inclusion and progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Chemoradiotherapy + Cetuximab n=99 Participants Chemoradiotherapy Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week)
Progression Free Survival	14.4 Months Interval 11.2 to 18.8

Adverse Events

Chemoradiotherapy + Cetuximab

Serious events: 26 serious events

Other events: 100 other events

Deaths: 51 deaths

Serious adverse events

Serious adverse events
Measure	Chemoradiotherapy + Cetuximab n=102 participants at risk Chemotherapy + cetuximab + radiotherapy Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week)
Vascular disorders Phlebitis superficial	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Vascular disorders Pulmonary embolism	3.9% 4/102 • Number of events 4 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Immune system disorders Hypersensitivity	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
General disorders Asthenia	2.0% 2/102 • Number of events 2 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
General disorders Fatigue	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
General disorders General physical health deterioration	6.9% 7/102 • Number of events 7 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
General disorders Death	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
General disorders Hyperthermia	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
General disorders Malaise	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
General disorders Pyrexia	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Investigations Hemoglobin decreased	2.0% 2/102 • Number of events 2 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Investigations Neutrophil count decreased	2.0% 2/102 • Number of events 2 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Investigations Platelet count decreased	2.0% 2/102 • Number of events 2 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Cardiac disorders Atrial fibrillation	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Cardiac disorders Myocardial infarction	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Cardiac disorders Pericardial effusion	2.0% 2/102 • Number of events 2 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Cardiac disorders Tachycardia	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Respiratory, thoracic and mediastinal disorders Lung disorder	2.9% 3/102 • Number of events 3 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Respiratory, thoracic and mediastinal disorders Respiratory tract infection	0.98% 1/102 • Number of events 3 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Respiratory, thoracic and mediastinal disorders Asthma	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Blood and lymphatic system disorders Bone marrow failure	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Blood and lymphatic system disorders Febrile neutropenia	4.9% 5/102 • Number of events 5 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Blood and lymphatic system disorders Anemia	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Nervous system disorders Carotid artery aneurysm	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Eye disorders Eye pain	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Colitis	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Constipation	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Dysphagia	2.9% 3/102 • Number of events 4 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Abdominal pain	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Faecaloma	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Nausea	2.9% 3/102 • Number of events 3 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Oesophagitis	3.9% 4/102 • Number of events 4 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Vomiting	3.9% 4/102 • Number of events 5 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Aphasia	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Renal and urinary disorders Acute kidney injury	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Renal and urinary disorders Hematuria	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Renal and urinary disorders Renal failure	2.0% 2/102 • Number of events 3 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Hepatobiliary disorders Cholecystitis	2.0% 2/102 • Number of events 2 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Musculoskeletal and connective tissue disorders Back pain	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Metabolism and nutrition disorders decreased appetite	2.0% 2/102 • Number of events 2 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Metabolism and nutrition disorders Dehydratation	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Metabolism and nutrition disorders Hypocalcemia	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Metabolism and nutrition disorders Hypokalemia	2.9% 3/102 • Number of events 3 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Infections and infestations device related infection	2.9% 3/102 • Number of events 3 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Infections and infestations Sepsis	2.0% 2/102 • Number of events 2 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Infections and infestations Urinary tract infection	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Infections and infestations Infection	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.98% 1/102 • Number of events 1 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.

Other adverse events

Other adverse events
Measure	Chemoradiotherapy + Cetuximab n=102 participants at risk Chemotherapy + cetuximab + radiotherapy Chemotherapy: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) ERBITUX: The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes Radiotherapy: 66 Gy (2 Gy by fraction, 5 fractions by week)
General disorders Alopecia	13.7% 14/102 • Number of events 28 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
General disorders Asthenia	76.5% 78/102 • Number of events 250 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
General disorders Chest pain	18.6% 19/102 • Number of events 47 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
General disorders Edema limb	6.9% 7/102 • Number of events 10 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
General disorders Fever	13.7% 14/102 • Number of events 23 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
General disorders Vertigo	5.9% 6/102 • Number of events 10 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
General disorders Weight loss	18.6% 19/102 • Number of events 50 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Investigations Hemoglobin decreased	61.8% 63/102 • Number of events 217 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Blood and lymphatic system disorders Neutrophil count decreased	78.4% 80/102 • Number of events 234 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Blood and lymphatic system disorders Platelet count decreased	60.8% 62/102 • Number of events 178 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Respiratory, thoracic and mediastinal disorders Cough	37.3% 38/102 • Number of events 94 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Respiratory, thoracic and mediastinal disorders Dysphonia	9.8% 10/102 • Number of events 28 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Respiratory, thoracic and mediastinal disorders Dyspnea	38.2% 39/102 • Number of events 94 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.7% 13/102 • Number of events 16 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Respiratory, thoracic and mediastinal disorders Hemoptysis	5.9% 6/102 • Number of events 9 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Nervous system disorders Neuropathy	6.9% 7/102 • Number of events 8 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Nervous system disorders Paresthesia	6.9% 7/102 • Number of events 12 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Eye disorders Conjunctivitis	8.8% 9/102 • Number of events 13 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Ear and labyrinth disorders Tinnitus	9.8% 10/102 • Number of events 28 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Anorexia	44.1% 45/102 • Number of events 106 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Constipation	38.2% 39/102 • Number of events 83 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Diarrhea	22.5% 23/102 • Number of events 34 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders dysgueusia	5.9% 6/102 • Number of events 8 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders dysphagia	63.7% 65/102 • Number of events 181 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Gastralgia	7.8% 8/102 • Number of events 12 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Nausea	74.5% 76/102 • Number of events 217 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Oral mucosal irritation	43.1% 44/102 • Number of events 92 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Pyrosis	5.9% 6/102 • Number of events 10 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Gastrointestinal disorders Vomiting	36.3% 37/102 • Number of events 69 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Renal and urinary disorders Renal failure	7.8% 8/102 • Number of events 21 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Skin and subcutaneous tissue disorders Acne	22.5% 23/102 • Number of events 80 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Skin and subcutaneous tissue disorders Dermatitis	26.5% 27/102 • Number of events 58 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Skin and subcutaneous tissue disorders Dry skin	29.4% 30/102 • Number of events 92 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Skin and subcutaneous tissue disorders Erythema	20.6% 21/102 • Number of events 46 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Skin and subcutaneous tissue disorders Folliculitis	35.3% 36/102 • Number of events 124 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Skin and subcutaneous tissue disorders Paronychia	6.9% 7/102 • Number of events 10 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Skin and subcutaneous tissue disorders Pruritus	6.9% 7/102 • Number of events 10 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Skin and subcutaneous tissue disorders Rash	31.4% 32/102 • Number of events 114 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Skin and subcutaneous tissue disorders Skin disorder	15.7% 16/102 • Number of events 46 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Metabolism and nutrition disorders Hypokalemia	6.9% 7/102 • Number of events 14 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.
Infections and infestations Mycosis	5.9% 6/102 • Number of events 7 • Adverse event were collected for a patient from the date of signature of his inform consent form until 30 days after the end of his study treatment. Deaths were collected through study completion.

Additional Information

Communications Officer

IFCT

Phone: +33156811045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place