Trial Outcomes & Findings for CetuGEX™ in Comparison to Cetuximab for the Treatment of Patients With Head and Neck Cancer (NCT NCT02052960)
NCT ID: NCT02052960
Last Updated: 2021-11-02
Results Overview
The primary efficacy endpoint was PFS as assessed by the investigator. Date of disease progression was defined as the date of imaging (based on computed tomography (CT) scans or magnetic resonance imaging (MRI)) showing disease progression, as assessed by the investigator according to adapted immune-related RECIST 1.1 (modified irRC). Disease progression was defined as a 20% increase in tumor burden, taking as reference the smallest tumor burden recorded since the treatment started; confirmation by a second scan was not required. The PFS time was censored at the time of the last tumor assessment if the patient was alive and without progression at the last time of observation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
240 participants
Primary outcome timeframe
The PFS was defined as time from randomization until disease progression or death of any cause, up to 24 month
Results posted on
2021-11-02
Participant Flow
Participant milestones
| Measure |
CetuGEX in Combination With Chemotherapy
CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly. Chemotherapy consisted of 5-FU (1000 mg/m2/d, day 1-4) and cisplatin (100 mg/m2, on day 1).Treatment cycles were scheduled to be repeated every 3 weeks for a maximum of 6 cycles, and followed by a weekly single-agent maintenance therapy of CetuGEX.
|
Cetuximab in Combination With Chemotherapy
Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA. Chemotherapy consisted of 5-FU (1000 mg/m2/d, day 1-4) and cisplatin (100 mg/m2, on day 1).Treatment cycles were scheduled to be repeated every 3 weeks for a maximum of 6 cycles, and followed by a weekly single-agent maintenance therapy of cetuximab.
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
123
|
|
Overall Study
Treated Patients
|
115
|
122
|
|
Overall Study
COMPLETED
|
63
|
77
|
|
Overall Study
NOT COMPLETED
|
54
|
46
|
Reasons for withdrawal
| Measure |
CetuGEX in Combination With Chemotherapy
CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly. Chemotherapy consisted of 5-FU (1000 mg/m2/d, day 1-4) and cisplatin (100 mg/m2, on day 1).Treatment cycles were scheduled to be repeated every 3 weeks for a maximum of 6 cycles, and followed by a weekly single-agent maintenance therapy of CetuGEX.
|
Cetuximab in Combination With Chemotherapy
Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA. Chemotherapy consisted of 5-FU (1000 mg/m2/d, day 1-4) and cisplatin (100 mg/m2, on day 1).Treatment cycles were scheduled to be repeated every 3 weeks for a maximum of 6 cycles, and followed by a weekly single-agent maintenance therapy of cetuximab.
|
|---|---|---|
|
Overall Study
Adverse Event
|
19
|
17
|
|
Overall Study
Protocol Violation
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
11
|
|
Overall Study
Other
|
25
|
15
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CetuGEX™ Plus Chemotherapy
n=117 Participants
720 mg weekly administration
CetuGEX™: 60 mg/day 0, 930 mg/day 1, followed by 720 mg i.v. weekly administration
Chemotherapy: Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)
|
Cetuximab Plus Chemotherapy
n=123 Participants
250 mg/m2 weekly administration
Cetuximab: 400 mg/sqm body surface area (BSA) on day 1, followed by 250 mg/sqm BSA i.v. weekly administration
Chemotherapy: Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=117 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=240 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=117 Participants
|
89 Participants
n=123 Participants
|
177 Participants
n=240 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=117 Participants
|
34 Participants
n=123 Participants
|
63 Participants
n=240 Participants
|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 7.54 • n=117 Participants
|
59.8 years
STANDARD_DEVIATION 7.91 • n=123 Participants
|
59.8 years
STANDARD_DEVIATION 7.72 • n=240 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=117 Participants
|
17 Participants
n=123 Participants
|
35 Participants
n=240 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=117 Participants
|
106 Participants
n=123 Participants
|
205 Participants
n=240 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Romania
|
24 participants
n=117 Participants
|
19 participants
n=123 Participants
|
43 participants
n=240 Participants
|
|
Region of Enrollment
Belgium
|
5 participants
n=117 Participants
|
8 participants
n=123 Participants
|
13 participants
n=240 Participants
|
|
Region of Enrollment
Poland
|
29 participants
n=117 Participants
|
29 participants
n=123 Participants
|
58 participants
n=240 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=117 Participants
|
7 participants
n=123 Participants
|
8 participants
n=240 Participants
|
|
Region of Enrollment
France
|
19 participants
n=117 Participants
|
25 participants
n=123 Participants
|
44 participants
n=240 Participants
|
|
Region of Enrollment
Germany
|
33 participants
n=117 Participants
|
29 participants
n=123 Participants
|
62 participants
n=240 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=117 Participants
|
6 participants
n=123 Participants
|
12 participants
n=240 Participants
|
PRIMARY outcome
Timeframe: The PFS was defined as time from randomization until disease progression or death of any cause, up to 24 monthPopulation: Intent-to-treat-population
The primary efficacy endpoint was PFS as assessed by the investigator. Date of disease progression was defined as the date of imaging (based on computed tomography (CT) scans or magnetic resonance imaging (MRI)) showing disease progression, as assessed by the investigator according to adapted immune-related RECIST 1.1 (modified irRC). Disease progression was defined as a 20% increase in tumor burden, taking as reference the smallest tumor burden recorded since the treatment started; confirmation by a second scan was not required. The PFS time was censored at the time of the last tumor assessment if the patient was alive and without progression at the last time of observation.
Outcome measures
| Measure |
CetuGEX
n=117 Participants
CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly
|
Cetuximab
n=123 Participants
Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
27.7 weeks
Interval 25.3 to 33.7
|
26.4 weeks
Interval 24.9 to 31.3
|
SECONDARY outcome
Timeframe: Time from randomization until disease progression or death, whichever occurs first, up to 24 month.Population: Intent-to-treat population
Objective response rate is the percentage of patients with a tumor size reduction of a predefined amount for a minimum time period and it is defined as the sum of complete responses (CR) and partial responses (PR). CR: Disappearance of all non-nodal target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the tumor burden (sum of the longest lesion diameter (LD) of target lesions (including the short axes of any target lymph nodes plus measurable new lesions), taking as reference the baseline sum diameters.
Outcome measures
| Measure |
CetuGEX
n=117 Participants
CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly
|
Cetuximab
n=123 Participants
Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
52 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Time from randomization until disease progression or death, whichever occurs first, up to 24 month.Population: Intent-to-treat population
The clinical benefit rate is the percentage of patients with an objective response or stable disease (SD). SD is defined as not meeting criteria of complete response and partial response, in absence of meeting criteria for disease progression. Follow-up measurements must have met the SD criteria at least once after randomization at a minimum interval of 8 weeks.
Outcome measures
| Measure |
CetuGEX
n=117 Participants
CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly
|
Cetuximab
n=123 Participants
Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA.
|
|---|---|---|
|
Clinical Benefit Rate
|
88 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: Time to treatment failure, defined as the interval between the date of randomization and the date of treatment discontinuation for any reason, up to 24 month.Time to treatment failure is defined as the time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.
Outcome measures
| Measure |
CetuGEX
n=116 Participants
CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly
|
Cetuximab
n=123 Participants
Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA.
|
|---|---|---|
|
Time to Treatment Failure
|
22.1 weeks
Interval 17.0 to 25.7
|
23.3 weeks
Interval 16.1 to 25.6
|
SECONDARY outcome
Timeframe: Time from randomization to the time of death, up to 24 month.Population: Intent-to-treat- population
The overall survival is defined as the duration of time from randomization to the time of death.
Outcome measures
| Measure |
CetuGEX
n=117 Participants
CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly
|
Cetuximab
n=123 Participants
Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA.
|
|---|---|---|
|
Overall Survival
|
49.7 weeks
Interval 40.7 to 73.9
|
59.0 weeks
Interval 52.9 to 70.3
|
SECONDARY outcome
Timeframe: From randomization up to end-of study visit, up to 24 monthPopulation: Intent-to treat population. 158 patients were evaluable for this Outcome Measure.
Quality of Life (QoL) scores as assessed by European Oncology Research Trials Committee (EORTC) QoL questionnaires (QLQ) EORTC-QLQ-C30. Scores are on a scale of 0 to 100, where 100 represents the highest possible QoL.Time to first deterioration of at least 10 points.
Outcome measures
| Measure |
CetuGEX
n=76 Participants
CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly
|
Cetuximab
n=82 Participants
Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA.
|
|---|---|---|
|
Time of Global Health Status Deterioration
|
43.4 weeks
Interval 14.0 to 61.4
|
31.3 weeks
Interval 11.7 to 63.0
|
Adverse Events
CetuGEX
Serious events: 70 serious events
Other events: 114 other events
Deaths: 20 deaths
Cetuximab
Serious events: 78 serious events
Other events: 121 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
CetuGEX
n=115 participants at risk
CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly
|
Cetuximab
n=122 participants at risk
Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
2.6%
3/115 • up to 24 month
|
1.6%
2/122 • up to 24 month
|
|
Investigations
Blood creatinine increased
|
1.7%
2/115 • up to 24 month
|
2.5%
3/122 • up to 24 month
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
2/115 • up to 24 month
|
0.82%
1/122 • up to 24 month
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
2/115 • up to 24 month
|
2.5%
3/122 • up to 24 month
|
|
Blood and lymphatic system disorders
Anemia
|
7.8%
9/115 • up to 24 month
|
7.4%
9/122 • up to 24 month
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.0%
8/115 • up to 24 month
|
5.7%
7/122 • up to 24 month
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
2/115 • up to 24 month
|
3.3%
4/122 • up to 24 month
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.6%
3/115 • up to 24 month
|
1.6%
2/122 • up to 24 month
|
|
Blood and lymphatic system disorders
Leucopenia
|
0.87%
1/115 • up to 24 month
|
3.3%
4/122 • up to 24 month
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
2/115 • up to 24 month
|
0.82%
1/122 • up to 24 month
|
|
General disorders
General physical health deterioration
|
1.7%
2/115 • up to 24 month
|
1.6%
2/122 • up to 24 month
|
|
General disorders
Device dislocation
|
0.87%
1/115 • up to 24 month
|
1.6%
2/122 • up to 24 month
|
|
General disorders
Fatigue
|
1.7%
2/115 • up to 24 month
|
0.82%
1/122 • up to 24 month
|
|
General disorders
Mucosal inflammation
|
2.6%
3/115 • up to 24 month
|
0.00%
0/122 • up to 24 month
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
3/115 • up to 24 month
|
1.6%
2/122 • up to 24 month
|
|
Gastrointestinal disorders
Nausea
|
2.6%
3/115 • up to 24 month
|
1.6%
2/122 • up to 24 month
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/115 • up to 24 month
|
1.6%
2/122 • up to 24 month
|
|
Renal and urinary disorders
Renal failure
|
1.7%
2/115 • up to 24 month
|
0.82%
1/122 • up to 24 month
|
|
Renal and urinary disorders
Renal failure acute
|
0.87%
1/115 • up to 24 month
|
1.6%
2/122 • up to 24 month
|
|
Metabolism and nutrition disorders
Dehydration
|
3.5%
4/115 • up to 24 month
|
4.1%
5/122 • up to 24 month
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.5%
4/115 • up to 24 month
|
4.1%
5/122 • up to 24 month
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.6%
3/115 • up to 24 month
|
3.3%
4/122 • up to 24 month
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
2/115 • up to 24 month
|
2.5%
3/122 • up to 24 month
|
|
Infections and infestations
Pneumonia
|
10.4%
12/115 • up to 24 month
|
7.4%
9/122 • up to 24 month
|
|
Infections and infestations
Sepsis
|
2.6%
3/115 • up to 24 month
|
5.7%
7/122 • up to 24 month
|
|
Infections and infestations
Device related infection
|
4.3%
5/115 • up to 24 month
|
3.3%
4/122 • up to 24 month
|
|
Infections and infestations
Lung abscess
|
0.00%
0/115 • up to 24 month
|
2.5%
3/122 • up to 24 month
|
Other adverse events
| Measure |
CetuGEX
n=115 participants at risk
CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly
|
Cetuximab
n=122 participants at risk
Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
13.9%
16/115 • Number of events 20 • up to 24 month
|
13.1%
16/122 • Number of events 24 • up to 24 month
|
|
Vascular disorders
Hypertension
|
9.6%
11/115 • Number of events 30 • up to 24 month
|
6.6%
8/122 • Number of events 13 • up to 24 month
|
|
General disorders
Fatigue
|
35.7%
41/115 • Number of events 82 • up to 24 month
|
31.1%
38/122 • Number of events 81 • up to 24 month
|
|
General disorders
Asthenia
|
29.6%
34/115 • Number of events 60 • up to 24 month
|
30.3%
37/122 • Number of events 75 • up to 24 month
|
|
General disorders
Mucosal inflammation
|
20.9%
24/115 • Number of events 45 • up to 24 month
|
29.5%
36/122 • Number of events 63 • up to 24 month
|
|
General disorders
Pyrexia
|
13.9%
16/115 • Number of events 17 • up to 24 month
|
19.7%
24/122 • Number of events 30 • up to 24 month
|
|
General disorders
Chills
|
22.6%
26/115 • Number of events 28 • up to 24 month
|
4.9%
6/122 • Number of events 6 • up to 24 month
|
|
General disorders
General physical health deterioration
|
6.1%
7/115 • Number of events 10 • up to 24 month
|
4.9%
6/122 • Number of events 6 • up to 24 month
|
|
Psychiatric disorders
Pulmonary embolism
|
7.0%
8/115 • Number of events 13 • up to 24 month
|
3.3%
4/122 • Number of events 5 • up to 24 month
|
|
Investigations
Weight decreased
|
36.5%
42/115 • Number of events 83 • up to 24 month
|
32.0%
39/122 • Number of events 72 • up to 24 month
|
|
Investigations
Blood creatinine increased
|
9.6%
11/115 • Number of events 19 • up to 24 month
|
6.6%
8/122 • Number of events 15 • up to 24 month
|
|
Investigations
Platelet count decreased
|
6.1%
7/115 • Number of events 13 • up to 24 month
|
4.9%
6/122 • Number of events 6 • up to 24 month
|
|
Cardiac disorders
Tachycardia
|
8.7%
10/115 • Number of events 11 • up to 24 month
|
2.5%
3/122 • Number of events 3 • up to 24 month
|
|
Blood and lymphatic system disorders
Anaemia
|
38.3%
44/115 • Number of events 104 • up to 24 month
|
45.9%
56/122 • Number of events 152 • up to 24 month
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.9%
47/115 • Number of events 105 • up to 24 month
|
41.8%
51/122 • Number of events 124 • up to 24 month
|
|
Blood and lymphatic system disorders
Leukopenia
|
28.7%
33/115 • Number of events 98 • up to 24 month
|
30.3%
37/122 • Number of events 90 • up to 24 month
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.3%
21/115 • Number of events 48 • up to 24 month
|
21.3%
26/122 • Number of events 69 • up to 24 month
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
10/115 • Number of events 10 • up to 24 month
|
12.3%
15/122 • Number of events 21 • up to 24 month
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.6%
11/115 • Number of events 17 • up to 24 month
|
11.5%
14/122 • Number of events 16 • up to 24 month
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.2%
6/115 • Number of events 7 • up to 24 month
|
8.2%
10/122 • Number of events 13 • up to 24 month
|
|
Nervous system disorders
Dizziness
|
12.2%
14/115 • Number of events 16 • up to 24 month
|
12.3%
15/122 • Number of events 20 • up to 24 month
|
|
Nervous system disorders
Headache
|
11.3%
13/115 • Number of events 16 • up to 24 month
|
10.7%
13/122 • Number of events 19 • up to 24 month
|
|
Nervous system disorders
Neuropathy periphera
|
2.6%
3/115 • Number of events 4 • up to 24 month
|
7.4%
9/122 • Number of events 19 • up to 24 month
|
|
Eye disorders
Conjunctivitis
|
8.7%
10/115 • Number of events 16 • up to 24 month
|
7.4%
9/122 • Number of events 12 • up to 24 month
|
|
Ear and labyrinth disorders
Vertigo
|
9.6%
11/115 • Number of events 13 • up to 24 month
|
9.8%
12/122 • Number of events 12 • up to 24 month
|
|
Ear and labyrinth disorders
Tinnitus
|
7.0%
8/115 • Number of events 10 • up to 24 month
|
4.9%
6/122 • Number of events 7 • up to 24 month
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.2%
6/115 • Number of events 6 • up to 24 month
|
5.7%
7/122 • Number of events 8 • up to 24 month
|
|
Gastrointestinal disorders
Nausea
|
50.4%
58/115 • Number of events 122 • up to 24 month
|
51.6%
63/122 • Number of events 162 • up to 24 month
|
|
Gastrointestinal disorders
Diarrhoea
|
33.0%
38/115 • Number of events 73 • up to 24 month
|
33.6%
41/122 • Number of events 84 • up to 24 month
|
|
Gastrointestinal disorders
Vomiting
|
30.4%
35/115 • Number of events 67 • up to 24 month
|
33.6%
41/122 • Number of events 83 • up to 24 month
|
|
Gastrointestinal disorders
Constipation
|
29.6%
34/115 • Number of events 47 • up to 24 month
|
18.9%
23/122 • Number of events 40 • up to 24 month
|
|
Gastrointestinal disorders
Stomatitis
|
22.6%
26/115 • Number of events 66 • up to 24 month
|
9.8%
12/122 • Number of events 21 • up to 24 month
|
|
Gastrointestinal disorders
Dysphagia
|
13.0%
15/115 • Number of events 20 • up to 24 month
|
13.1%
16/122 • Number of events 22 • up to 24 month
|
|
Gastrointestinal disorders
Dyspepsia
|
13.0%
15/115 • Number of events 23 • up to 24 month
|
10.7%
13/122 • Number of events 19 • up to 24 month
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
7/115 • Number of events 17 • up to 24 month
|
9.8%
12/122 • Number of events 13 • up to 24 month
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
9/115 • Number of events 11 • up to 24 month
|
4.9%
6/122 • Number of events 6 • up to 24 month
|
|
Renal and urinary disorders
Renal failure
|
4.3%
5/115 • Number of events 7 • up to 24 month
|
9.0%
11/122 • Number of events 16 • up to 24 month
|
|
Skin and subcutaneous tissue disorders
Rash
|
38.3%
44/115 • Number of events 116 • up to 24 month
|
38.5%
47/122 • Number of events 127 • up to 24 month
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
26.1%
30/115 • Number of events 106 • up to 24 month
|
17.2%
21/122 • Number of events 64 • up to 24 month
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.4%
20/115 • Number of events 23 • up to 24 month
|
18.9%
23/122 • Number of events 26 • up to 24 month
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
16.5%
19/115 • Number of events 38 • up to 24 month
|
13.9%
17/122 • Number of events 36 • up to 24 month
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.7%
10/115 • Number of events 23 • up to 24 month
|
9.0%
11/122 • Number of events 40 • up to 24 month
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.8%
9/115 • Number of events 10 • up to 24 month
|
9.0%
11/122 • Number of events 13 • up to 24 month
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.0%
8/115 • Number of events 8 • up to 24 month
|
6.6%
8/122 • Number of events 10 • up to 24 month
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.7%
10/115 • Number of events 16 • up to 24 month
|
3.3%
4/122 • Number of events 6 • up to 24 month
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
6/115 • Number of events 9 • up to 24 month
|
5.7%
7/122 • Number of events 8 • up to 24 month
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
46.1%
53/115 • Number of events 146 • up to 24 month
|
41.8%
51/122 • Number of events 181 • up to 24 month
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.3%
36/115 • Number of events 47 • up to 24 month
|
24.6%
30/122 • Number of events 48 • up to 24 month
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.4%
20/115 • Number of events 35 • up to 24 month
|
18.0%
22/122 • Number of events 53 • up to 24 month
|
|
Metabolism and nutrition disorders
Dehydration
|
8.7%
10/115 • Number of events 11 • up to 24 month
|
10.7%
13/122 • Number of events 14 • up to 24 month
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.7%
10/115 • Number of events 19 • up to 24 month
|
10.7%
13/122 • Number of events 20 • up to 24 month
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.6%
11/115 • Number of events 14 • up to 24 month
|
7.4%
9/122 • Number of events 9 • up to 24 month
|
|
Infections and infestations
Paronychia
|
13.9%
16/115 • Number of events 36 • up to 24 month
|
9.8%
12/122 • Number of events 19 • up to 24 month
|
|
Infections and infestations
Pneumonia
|
11.3%
13/115 • Number of events 17 • up to 24 month
|
9.8%
12/122 • Number of events 14 • up to 24 month
|
|
Infections and infestations
Urinary tract infection
|
6.1%
7/115 • Number of events 12 • up to 24 month
|
4.9%
6/122 • Number of events 7 • up to 24 month
|
|
Infections and infestations
Bronchitis
|
2.6%
3/115 • Number of events 3 • up to 24 month
|
7.4%
9/122 • Number of events 14 • up to 24 month
|
|
Infections and infestations
Device related infection
|
7.0%
8/115 • Number of events 8 • up to 24 month
|
3.3%
4/122 • Number of events 5 • up to 24 month
|
|
Infections and infestations
Sepsis
|
3.5%
4/115 • Number of events 4 • up to 24 month
|
6.6%
8/122 • Number of events 8 • up to 24 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication, presentation or use of the methods and/or results of the clinical trial are not permitted without prior written sponsor´s consent.
- Publication restrictions are in place
Restriction type: OTHER