Trial Outcomes & Findings for Cetuximab and Pembrolizumab in Treating Patients With Colorectal Cancer That is Metastatic or Cannot Be Removed by Surgery (NCT NCT02713373)
NCT ID: NCT02713373
Last Updated: 2022-10-06
Results Overview
The frequency of toxicities will be tabulated by maximum grade by preferred term within a patient across all cycles.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
up to 24 months
Results posted on
2022-10-06
Participant Flow
Forty-five patients were enrolled in our study; one patient was not treated secondary to clinical progression during the screening period
Participant milestones
| Measure |
Arm I (Cetuximab and Pembrolizumab)
Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cetuximab and Pembrolizumab in Treating Patients With Colorectal Cancer That is Metastatic or Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm I (Cetuximab and Pembrolizumab)
n=44 Participants
Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 monthsThe frequency of toxicities will be tabulated by maximum grade by preferred term within a patient across all cycles.
Outcome measures
| Measure |
Arm I (Cetuximab and Pembrolizumab)
n=44 Participants
Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
To Examine the Adverse Event Profile
Dry skin
|
21 participants
|
|
To Examine the Adverse Event Profile
acneiform dermatitis
|
20 participants
|
|
To Examine the Adverse Event Profile
fatigue
|
17 participants
|
|
To Examine the Adverse Event Profile
hypomagnesemia
|
16 participants
|
|
To Examine the Adverse Event Profile
rash
|
16 participants
|
|
To Examine the Adverse Event Profile
diarrhea
|
12 participants
|
|
To Examine the Adverse Event Profile
pruritus
|
12 participants
|
|
To Examine the Adverse Event Profile
anorexia
|
10 participants
|
PRIMARY outcome
Timeframe: At 6 monthsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), At least a 20% increase in the sum of diameters of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Arm I (Cetuximab and Pembrolizumab)
n=44 Participants
Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Progression Free Survival (PFS), Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
|
31 percentage of PFS at 6 months
Interval 20.0 to 43.0
|
PRIMARY outcome
Timeframe: Up to 2 yearsNumber of Participants with a Response, Evaluated According to RECIST 1.1 will be tabulated and will be compared to the null values using exact tests.
Outcome measures
| Measure |
Arm I (Cetuximab and Pembrolizumab)
n=44 Participants
Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Number of Participants With a Response, Evaluated According to RECIST 1.1
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 24 monthstumor response using immune-related RECIST (irRECIST) will be tabulated, summarized and reported.
Outcome measures
| Measure |
Arm I (Cetuximab and Pembrolizumab)
n=44 Participants
Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Objective Tumor Response Using Immune-related RECIST
PD Progressive Disease
|
11 Participants
|
|
Objective Tumor Response Using Immune-related RECIST
PR Partial Response/Remission
|
1 Participants
|
|
Objective Tumor Response Using Immune-related RECIST
SD Stable Disease
|
27 Participants
|
|
Objective Tumor Response Using Immune-related RECIST
TE Too Early
|
1 Participants
|
|
Objective Tumor Response Using Immune-related RECIST
NE Not Evaluable
|
3 Participants
|
|
Objective Tumor Response Using Immune-related RECIST
OT Other
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to death, withdrawal of consent, or the end of the study, whichever occurs first, assessed up to 2 yearsDistributions of OS will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm I (Cetuximab and Pembrolizumab)
n=44 Participants
Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Survival (OS)
|
14.5 months
Interval 11.6 to 19.6
|
SECONDARY outcome
Timeframe: Up to15 monthsDistributions of PFS will be estimated using the Kaplan-Meier method. Median PFS is reported.
Outcome measures
| Measure |
Arm I (Cetuximab and Pembrolizumab)
n=44 Participants
Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Progression Free Survival (PFS)
|
4.1 Months
Interval 3.9 to 6.0
|
Adverse Events
Arm I (Cetuximab and Pembrolizumab)
Serious events: 9 serious events
Other events: 44 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Arm I (Cetuximab and Pembrolizumab)
n=44 participants at risk
Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Oesophageal perforation
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
General disorders
Chest pain
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
General disorders
Pyrexia
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Abdominal infection
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Encephalitis
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/44 • Number of events 2 • up to 24 months
|
|
Infections and infestations
Urosepsis
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.8%
3/44 • Number of events 3 • up to 24 months
|
Other adverse events
| Measure |
Arm I (Cetuximab and Pembrolizumab)
n=44 participants at risk
Patients receive cetuximab IV over 120 minutes on day 1 (days 1, 7, and 14 of course 1 only) and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 24 months in the absence of disease progression or unacceptable toxicity. Patients may continue pembrolizumab treatment for up to 1 year if they experience disease progression.
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.9%
7/44 • Number of events 26 • up to 24 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.5%
2/44 • Number of events 4 • up to 24 months
|
|
Cardiac disorders
Sinus tachycardia
|
4.5%
2/44 • Number of events 2 • up to 24 months
|
|
Cardiac disorders
Tachycardia
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Ear and labyrinth disorders
Ear pain
|
4.5%
2/44 • Number of events 2 • up to 24 months
|
|
Endocrine disorders
Hyperthyroidism
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Endocrine disorders
Hypothyroidism
|
6.8%
3/44 • Number of events 3 • up to 24 months
|
|
Eye disorders
Eye disorder
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Eye disorders
Eye pruritus
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Eye disorders
Papilloedema
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Eye disorders
Vision blurred
|
6.8%
3/44 • Number of events 3 • up to 24 months
|
|
Eye disorders
Visual impairment
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal distension
|
4.5%
2/44 • Number of events 2 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
4/44 • Number of events 4 • up to 24 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Ascites
|
4.5%
2/44 • Number of events 3 • up to 24 months
|
|
Gastrointestinal disorders
Constipation
|
31.8%
14/44 • Number of events 22 • up to 24 months
|
|
Gastrointestinal disorders
Diarrhoea
|
34.1%
15/44 • Number of events 26 • up to 24 months
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
4/44 • Number of events 5 • up to 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
6.8%
3/44 • Number of events 3 • up to 24 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Gingival pain
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Lip dry
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
22.7%
10/44 • Number of events 20 • up to 24 months
|
|
Gastrointestinal disorders
Oral pain
|
4.5%
2/44 • Number of events 2 • up to 24 months
|
|
Gastrointestinal disorders
Pancreatitis
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Proctalgia
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Rectal discharge
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Gastrointestinal disorders
Stomatitis
|
15.9%
7/44 • Number of events 8 • up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
20.5%
9/44 • Number of events 14 • up to 24 months
|
|
General disorders
Catheter site related reaction
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
General disorders
Chills
|
13.6%
6/44 • Number of events 6 • up to 24 months
|
|
General disorders
Facial pain
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
General disorders
Fatigue
|
40.9%
18/44 • Number of events 31 • up to 24 months
|
|
General disorders
Influenza like illness
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
General disorders
Infusion site reaction
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
General disorders
Mucosal inflammation
|
4.5%
2/44 • Number of events 2 • up to 24 months
|
|
General disorders
Oedema
|
4.5%
2/44 • Number of events 2 • up to 24 months
|
|
General disorders
Oedema peripheral
|
11.4%
5/44 • Number of events 5 • up to 24 months
|
|
General disorders
Pain
|
6.8%
3/44 • Number of events 3 • up to 24 months
|
|
General disorders
Pyrexia
|
15.9%
7/44 • Number of events 8 • up to 24 months
|
|
General disorders
Tenderness
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Immune system disorders
Seasonal allergy
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Candida infection
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Conjunctivitis
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Infection
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Lung infection
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Paronychia
|
4.5%
2/44 • Number of events 3 • up to 24 months
|
|
Infections and infestations
Pneumonia
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Rash pustular
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
1/44 • Number of events 3 • up to 24 months
|
|
Infections and infestations
Urinary tract infection
|
6.8%
3/44 • Number of events 3 • up to 24 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
20.5%
9/44 • Number of events 10 • up to 24 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Injury, poisoning and procedural complications
Sunburn
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
4/44 • Number of events 14 • up to 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
11.4%
5/44 • Number of events 8 • up to 24 months
|
|
Investigations
Blood alkaline phosphatase
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Investigations
Blood alkaline phosphatase increased
|
9.1%
4/44 • Number of events 6 • up to 24 months
|
|
Investigations
Blood bilirubin increased
|
4.5%
2/44 • Number of events 3 • up to 24 months
|
|
Investigations
Blood creatinine increased
|
6.8%
3/44 • Number of events 23 • up to 24 months
|
|
Investigations
Blood magnesium decreased
|
4.5%
2/44 • Number of events 2 • up to 24 months
|
|
Investigations
Carbon dioxide decreased
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Investigations
International normalised ratio
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Investigations
International normalised ratio increased
|
2.3%
1/44 • Number of events 3 • up to 24 months
|
|
Investigations
Lymphocyte count decreased
|
9.1%
4/44 • Number of events 11 • up to 24 months
|
|
Investigations
Lymphocyte count increased
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Investigations
Platelet count decreased
|
2.3%
1/44 • Number of events 2 • up to 24 months
|
|
Investigations
Transaminases increased
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Investigations
Troponin increased
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Investigations
Weight decreased
|
4.5%
2/44 • Number of events 2 • up to 24 months
|
|
Investigations
Weight increased
|
2.3%
1/44 • Number of events 3 • up to 24 months
|
|
Investigations
White blood cell count decreased
|
2.3%
1/44 • Number of events 4 • up to 24 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.7%
10/44 • Number of events 17 • up to 24 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.1%
4/44 • Number of events 12 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.6%
6/44 • Number of events 22 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
38.6%
17/44 • Number of events 54 • up to 24 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.8%
3/44 • Number of events 12 • up to 24 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
4/44 • Number of events 6 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.6%
6/44 • Number of events 10 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.5%
2/44 • Number of events 2 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.8%
3/44 • Number of events 4 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.3%
1/44 • Number of events 3 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.8%
3/44 • Number of events 3 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
2/44 • Number of events 2 • up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Dizziness
|
11.4%
5/44 • Number of events 5 • up to 24 months
|
|
Nervous system disorders
Drooling
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Headache
|
15.9%
7/44 • Number of events 7 • up to 24 months
|
|
Nervous system disorders
Hyperaesthesia
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Neuropathy peripheral
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.8%
3/44 • Number of events 3 • up to 24 months
|
|
Nervous system disorders
Sciatica
|
2.3%
1/44 • Number of events 2 • up to 24 months
|
|
Nervous system disorders
Taste disorder
|
6.8%
3/44 • Number of events 3 • up to 24 months
|
|
Psychiatric disorders
Agitation
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Psychiatric disorders
Depression
|
4.5%
2/44 • Number of events 2 • up to 24 months
|
|
Psychiatric disorders
Insomnia
|
18.2%
8/44 • Number of events 12 • up to 24 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Renal and urinary disorders
Proteinuria
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
11/44 • Number of events 19 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.7%
10/44 • Number of events 17 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.8%
3/44 • Number of events 3 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/44 • Number of events 2 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.8%
3/44 • Number of events 5 • up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
45.5%
20/44 • Number of events 32 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
2.3%
1/44 • Number of events 2 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
47.7%
21/44 • Number of events 26 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
2/44 • Number of events 2 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
6.8%
3/44 • Number of events 3 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
15.9%
7/44 • Number of events 7 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Nail growth abnormal
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
4.5%
2/44 • Number of events 2 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
6.8%
3/44 • Number of events 3 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
29.5%
13/44 • Number of events 14 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
36.4%
16/44 • Number of events 24 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.5%
2/44 • Number of events 3 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
6.8%
3/44 • Number of events 4 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Flushing
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Hot flush
|
2.3%
1/44 • Number of events 1 • up to 24 months
|
|
Vascular disorders
Hypertension
|
6.8%
3/44 • Number of events 46 • up to 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place