Trial Outcomes & Findings for CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab (NCT NCT03638141)
NCT ID: NCT03638141
Last Updated: 2025-08-17
Results Overview
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on mRECIST criteria. CR = Disappearance of any intratumoral arterial enhancement in all target lesions, PR = At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
up to 26 months
Results posted on
2025-08-17
Participant Flow
Participant milestones
| Measure |
Durvalumab in Combination With Tremelimumab
Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure.
Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 cycles or until confirmed disease progression.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Durvalumab in Combination With Tremelimumab
Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure.
Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 cycles or until confirmed disease progression.
|
|---|---|
|
Overall Study
1 subject was removed from the study due to non compliance and was never treated.
|
1
|
Baseline Characteristics
CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab
Baseline characteristics by cohort
| Measure |
Durvalumab in Combination With Tremelimumab
n=20 Participants
Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure.
Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 cycles or until confirmed disease progression.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 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
|
|
Hepatitis B or C
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 26 monthsPopulation: Participants who received at least one dose of study drug
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on mRECIST criteria. CR = Disappearance of any intratumoral arterial enhancement in all target lesions, PR = At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.
Outcome measures
| Measure |
Durvalumab in Combination With Tremelimumab
n=20 Participants
Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure.
Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 cycles or until confirmed disease progression.
|
|---|---|
|
Objective Response Rate (ORR)
|
11 Participants
|
SECONDARY outcome
Timeframe: up to 16 monthsPopulation: Participants who received at least one dose of study drug
Number of participants experiencing drug-related adverse events (AE) Grade 3 or higher as defined by CTCAE v5.0
Outcome measures
| Measure |
Durvalumab in Combination With Tremelimumab
n=20 Participants
Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure.
Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 cycles or until confirmed disease progression.
|
|---|---|
|
Drug-related Toxicity
Any gr 3 or higher AE
|
4 Participants
|
|
Drug-related Toxicity
Hepatitis
|
1 Participants
|
|
Drug-related Toxicity
Diarrhea
|
1 Participants
|
|
Drug-related Toxicity
Myalgia
|
1 Participants
|
|
Drug-related Toxicity
Myocarditis
|
1 Participants
|
|
Drug-related Toxicity
Myositis
|
1 Participants
|
|
Drug-related Toxicity
Nausea
|
1 Participants
|
|
Drug-related Toxicity
Pericarditis
|
1 Participants
|
|
Drug-related Toxicity
Pruritus
|
1 Participants
|
|
Drug-related Toxicity
Rash maculo-papular
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 58 monthsPopulation: Participants who received at least one dose of study drug
Progression free survival is defined as the time from start of the treatment until the documentation of disease progression according to mRECIST or death due to any cause, whichever occurs first. Estimation based on the Kaplan-Meier curve.
Outcome measures
| Measure |
Durvalumab in Combination With Tremelimumab
n=20 Participants
Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure.
Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 cycles or until confirmed disease progression.
|
|---|---|
|
Progression Free Survival (PFS)
|
6.1 months
Interval 3.3 to
NA Explanation: Upper bound confidence interval was not estimable due to insufficient number of events
|
SECONDARY outcome
Timeframe: up to 58 monthsPopulation: Participants who received at least one dose of study drug
Overall survival is the time from the start of first dose of study drug to death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Outcome measures
| Measure |
Durvalumab in Combination With Tremelimumab
n=20 Participants
Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure.
Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 cycles or until confirmed disease progression.
|
|---|---|
|
Overall Survival (OS)
|
28.8 months
Interval 15.1 to
NA Explanation: Upper bound confidence interval was not estimable due to insufficient number of events
|
Adverse Events
Durvalumab in Combination With Tremelimumab
Serious events: 10 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Durvalumab in Combination With Tremelimumab
n=20 participants at risk
Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure.
Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 doses/cycles.
Durvalumab: Durvalumab 1500mg IV every 4 weeks for up to a maximum of 13 cycles (about 12 months) or until confirmed disease progression.
Tremelimumab: Tremelimumab 300 mg IV in combination with Durvalumab 1500mg about 2 weeks after their first DEB-TACE.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Immune system disorders
Autoimmune disorder (hepatitis)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Cardiac disorders
Post-embolization syndrome
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Cardiac disorders
Myocarditis
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Cardiac disorders
Pericarditis
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Psychiatric disorders
Psychosis
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Cardiac disorders
Sinus bradycardia
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Psychiatric disorders
Suicidal ideation
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
General disorders
Multi organ failure
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
Other adverse events
| Measure |
Durvalumab in Combination With Tremelimumab
n=20 participants at risk
Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure.
Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 doses/cycles.
Durvalumab: Durvalumab 1500mg IV every 4 weeks for up to a maximum of 13 cycles (about 12 months) or until confirmed disease progression.
Tremelimumab: Tremelimumab 300 mg IV in combination with Durvalumab 1500mg about 2 weeks after their first DEB-TACE.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Abdominal pain
|
60.0%
12/20 • Number of events 18 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.0%
3/20 • Number of events 3 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Anal hemorrhage
|
5.0%
1/20 • Number of events 2 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Metabolism and nutrition disorders
Anorexia
|
35.0%
7/20 • Number of events 8 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • Number of events 4 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Ascites
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
3/20 • Number of events 5 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Bloating
|
10.0%
2/20 • Number of events 2 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Investigations
Blood bilirubin increased
|
10.0%
2/20 • Number of events 2 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Reproductive system and breast disorders
Breast pain
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Psychiatric disorders
Confusion
|
20.0%
4/20 • Number of events 4 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Constipation
|
40.0%
8/20 • Number of events 9 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Investigations
Creatinine increased
|
5.0%
1/20 • Number of events 2 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
6/20 • Number of events 10 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Eye disorders
Dry eye
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
2/20 • Number of events 3 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Nervous system disorders
Dysgeusia
|
10.0%
2/20 • Number of events 2 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Nervous system disorders
Dyspnea
|
15.0%
3/20 • Number of events 3 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
General disorders
Edema limbs
|
30.0%
6/20 • Number of events 6 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Esophagitis
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
General disorders
Fatigue
|
80.0%
16/20 • Number of events 24 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
General disorders
Fever
|
45.0%
9/20 • Number of events 11 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
15.0%
3/20 • Number of events 3 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
General disorders
Flu like symptoms
|
10.0%
2/20 • Number of events 3 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
General disorders
Gait disturbance
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
General disorders
Pain (biopsy site)
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
2/20 • Number of events 3 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 7 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
2/20 • Number of events 2 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
2/20 • Number of events 3 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Investigations
INR increased
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Infections and infestations
Lung infection
|
10.0%
2/20 • Number of events 2 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Nausea
|
35.0%
7/20 • Number of events 12 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
2/20 • Number of events 2 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Nervous system disorders
Neuralgia
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
General disorders
Non-cardiac chest pain
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
2/20 • Number of events 3 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Nervous system disorders
Paresthesia
|
10.0%
2/20 • Number of events 2 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Investigations
Platelet count decreased
|
15.0%
3/20 • Number of events 3 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Nervous system disorders
Presyncope
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
55.0%
11/20 • Number of events 15 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
55.0%
11/20 • Number of events 18 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
2/20 • Number of events 2 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Psychiatric disorders
Suicidal ideation
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Infections and infestations
Thrush
|
5.0%
1/20 • Number of events 1 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
2/20 • Number of events 2 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Number of events 5 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Investigations
Weight loss
|
35.0%
7/20 • Number of events 11 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
|
Investigations
White blood cell decreased
|
10.0%
2/20 • Number of events 2 • From first dose of study drug up to 58 months
Participants who received at least one dose of study drug were considered at risk
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place