Trial Outcomes & Findings for Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma (NCT NCT01843374)
NCT ID: NCT01843374
Last Updated: 2025-11-14
Results Overview
Overall survival (OS) by treatment arm
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
571 participants
Primary outcome timeframe
3 years.
Results posted on
2025-11-14
Participant Flow
A total of 658 patients were screened, 87 patients were excluded from randomisation and 571 patients were randomised: Of the 78 excluded, 66 did not meet inclusion/exclusion criteria; 19 withdrew consent and 2 were excluded for other reasons.
Participant milestones
| Measure |
PLACEBO
Placebo.
|
TREMELIMUMAB
TREMELIMUMAB 10 mg/kg
|
|---|---|---|
|
Overall Study
STARTED
|
189
|
382
|
|
Overall Study
RANDOMIZED
|
189
|
382
|
|
Overall Study
COMPLETED
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
189
|
379
|
Reasons for withdrawal
| Measure |
PLACEBO
Placebo.
|
TREMELIMUMAB
TREMELIMUMAB 10 mg/kg
|
|---|---|---|
|
Overall Study
Death
|
155
|
313
|
|
Overall Study
Withdrawal by Subject
|
14
|
20
|
|
Overall Study
Withdrawing due to Other reason
|
20
|
46
|
Baseline Characteristics
Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma
Baseline characteristics by cohort
| Measure |
TREMELIMUMAB
n=382 Participants
TREMELIMUMAB 10 mg/kg
|
PLACEBO
n=189 Participants
Placebo.
|
Total
n=571 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.2 Years
STANDARD_DEVIATION 9.24 • n=10 Participants
|
66.3 Years
STANDARD_DEVIATION 8.8 • n=10 Participants
|
65.6 Years
STANDARD_DEVIATION 9.10 • n=20 Participants
|
|
Age, Customized
< 65 years
|
162 Participants
n=10 Participants
|
75 Participants
n=10 Participants
|
237 Participants
n=20 Participants
|
|
Age, Customized
>= 65 years
|
220 Participants
n=10 Participants
|
114 Participants
n=10 Participants
|
334 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=10 Participants
|
38 Participants
n=10 Participants
|
137 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
283 Participants
n=10 Participants
|
151 Participants
n=10 Participants
|
434 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 3 years.Population: ITT population
Overall survival (OS) by treatment arm
Outcome measures
| Measure |
PLACEBO
n=189 Participants
Placebo.
|
TREMELIMUMAB
n=282 Participants
TREMELIMUMAB 10 mg/kg
|
|---|---|---|
|
Overall Survival (OS)
Number of patients with Events (Death)
|
154 Number of Participants
|
307 Number of Participants
|
|
Overall Survival (OS)
Number patients censored <= 2 weeks before DCO
|
25 Number of Participants
|
58 Number of Participants
|
|
Overall Survival (OS)
Number of patients censored > 2 weeks before DCO
|
10 Number of Participants
|
17 Number of Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: ITT population
The percentage of patients still alive at 18 months
Outcome measures
| Measure |
PLACEBO
n=382 Participants
Placebo.
|
TREMELIMUMAB
n=189 Participants
TREMELIMUMAB 10 mg/kg
|
|---|---|---|
|
OS Rate at 18 Months by Treatment Arm
|
17.4 Percentage of Participants
Interval 13.4 to 21.8
|
18.2 Percentage of Participants
Interval 12.7 to 24.5
|
SECONDARY outcome
Timeframe: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.Population: ITT population
Progression-free survival will be measured from randomization to the first documentation of disease progression or death due to any cause, whichever occurs first. Progression is defined using the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI), 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
| Measure |
PLACEBO
n=382 Participants
Placebo.
|
TREMELIMUMAB
n=189 Participants
TREMELIMUMAB 10 mg/kg
|
|---|---|---|
|
Progression-free Survival by Treatment Arm
|
2.69 Months
Interval 2.66 to 2.76
|
2.76 Months
Interval 2.76 to 2.79
|
SECONDARY outcome
Timeframe: Time from randomization to best response to treatment, assessed up to 3 years.Population: ITT population
Overall response rate is defined as the proportion of participants with confirmed CR or PR per the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete Response (CR) corresponds to disappearance of all target lesions, and Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
PLACEBO
n=382 Participants
Placebo.
|
TREMELIMUMAB
n=189 Participants
TREMELIMUMAB 10 mg/kg
|
|---|---|---|
|
Overall Response Rate by Treatment Arm
|
4.5 Percentage
Interval 2.6 to 7.0
|
1.1 Percentage
Interval 0.1 to 3.8
|
SECONDARY outcome
Timeframe: Duration of response from the first documentation of objcetive response (confirmed CR or PR) to the first documented disease progression, assessed up to 14 weeks after the initial response.Population: ITT
Duration of response will be defined as the duration from the first documentation of complete response (CR), partial response (PR) to the first documented disease progression.
Outcome measures
| Measure |
PLACEBO
n=382 Participants
Placebo.
|
TREMELIMUMAB
n=189 Participants
TREMELIMUMAB 10 mg/kg
|
|---|---|---|
|
Duration of Response by Treatment Arm
|
4.8 Months
Interval 0.0 to 13.4
|
5.57 Months
Interval 2.8 to 8.3
|
SECONDARY outcome
Timeframe: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.Population: ITT population
Disease control rate (DCR) is defined as the proportion of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 12 weeks duration
Outcome measures
| Measure |
PLACEBO
n=382 Participants
Placebo.
|
TREMELIMUMAB
n=189 Participants
TREMELIMUMAB 10 mg/kg
|
|---|---|---|
|
Disease Control Rate by Treatment Arm
|
21.7 Percentage
Interval 16.0 to 28.3
|
27.7 Percentage
Interval 23.3 to 32.5
|
SECONDARY outcome
Timeframe: Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.Population: ITT population
Durable disease control rate (DDCR) is defined as the percentage of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 6 months duration
Outcome measures
| Measure |
PLACEBO
n=382 Participants
Placebo.
|
TREMELIMUMAB
n=189 Participants
TREMELIMUMAB 10 mg/kg
|
|---|---|---|
|
Durable Disease Control Rate by Treatment Arm
|
16.8 Percentage
Interval 13.1 to 20.9
|
11.6 Percentage
Interval 7.4 to 17.1
|
SECONDARY outcome
Timeframe: Day 1- 90 days post dosePopulation: Safety population
Any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
PLACEBO
n=380 Participants
Placebo.
|
TREMELIMUMAB
n=189 Participants
TREMELIMUMAB 10 mg/kg
|
|---|---|---|
|
Number of Participants Reporting Any Adverse Event
|
364 Participants
|
179 Participants
|
SECONDARY outcome
Timeframe: Day 1 to 90 days post dosePopulation: Safety population
Outcome measures
| Measure |
PLACEBO
n=189 Participants
Placebo.
|
TREMELIMUMAB
n=380 Participants
TREMELIMUMAB 10 mg/kg
|
|---|---|---|
|
Number of Participants Reporting Any Serious Adverse Events
|
85 Participants
|
218 Participants
|
SECONDARY outcome
Timeframe: Week 5Population: Safety population
The immunogenicity titer is reported for samples confirmed positive for the presence of anti tremelimumab antibodies.
Outcome measures
| Measure |
PLACEBO
n=188 Participants
Placebo.
|
TREMELIMUMAB
n=377 Participants
TREMELIMUMAB 10 mg/kg
|
|---|---|---|
|
Number of Participants With Positive Anti-drug Antibodies
|
0 Participants
|
15 Participants
|
Adverse Events
PLACEBO
Serious events: 85 serious events
Other events: 159 other events
Deaths: 160 deaths
TREMELIMUMAB
Serious events: 218 serious events
Other events: 338 other events
Deaths: 318 deaths
Serious adverse events
| Measure |
PLACEBO
n=189 participants at risk
Placebo.
|
TREMELIMUMAB
n=380 participants at risk
Tremelimumab 10mg/kg
|
|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/189
|
1.3%
5/380 • Number of events 5
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
7/189 • Number of events 9
|
3.2%
12/380 • Number of events 13
|
|
General disorders
Asthenia
|
1.6%
3/189 • Number of events 3
|
1.1%
4/380 • Number of events 5
|
|
General disorders
Device breakage
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
General disorders
Device dislocation
|
0.00%
0/189
|
0.26%
1/380 • Number of events 2
|
|
General disorders
Early satiety
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
General disorders
Fatigue
|
1.1%
2/189 • Number of events 2
|
0.79%
3/380 • Number of events 4
|
|
General disorders
General physical health deterioration
|
2.1%
4/189 • Number of events 4
|
2.4%
9/380 • Number of events 10
|
|
General disorders
Malaise
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
General disorders
Multi-organ failure
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
2.1%
4/189 • Number of events 4
|
0.53%
2/380 • Number of events 2
|
|
General disorders
Oedema
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
General disorders
Oedema peripheral
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
General disorders
Pain
|
1.6%
3/189 • Number of events 4
|
0.00%
0/380
|
|
General disorders
Pyrexia
|
0.00%
0/189
|
2.9%
11/380 • Number of events 12
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Anal abscess
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Infections and infestations
Appendicitis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 3
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Encephalitis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/189
|
0.26%
1/380 • Number of events 3
|
|
Infections and infestations
Lower respiratory tract infection
|
0.53%
1/189 • Number of events 1
|
0.79%
3/380 • Number of events 3
|
|
Infections and infestations
Lung infection
|
1.1%
2/189 • Number of events 2
|
1.3%
5/380 • Number of events 8
|
|
Infections and infestations
Lymphangitis
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Infections and infestations
Meningitis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
3.2%
6/189 • Number of events 8
|
2.9%
11/380 • Number of events 13
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Infections and infestations
Sepsis
|
0.53%
1/189 • Number of events 1
|
1.6%
6/380 • Number of events 7
|
|
Infections and infestations
Septic shock
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Infections and infestations
Systemic mycosis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/189
|
0.79%
3/380 • Number of events 3
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.53%
1/189 • Number of events 1
|
1.1%
4/380 • Number of events 4
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Vascular disorders
Superior vena cava syndrome
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Vascular disorders
Vena cava thrombosis
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Investigations
Amylase increased
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Investigations
Blood creatinine increased
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Investigations
C-reactive protein increased
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Vascular disorders
Venous stenosis
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Investigations
Platelet count decreased
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Investigations
Troponin T increased
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Investigations
Weight decreased
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.53%
1/189 • Number of events 1
|
2.6%
10/380 • Number of events 12
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/189
|
0.26%
1/380 • Number of events 2
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/189
|
0.26%
1/380 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.53%
1/189 • Number of events 1
|
0.53%
2/380 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/189
|
0.79%
3/380 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
2/189 • Number of events 2
|
0.00%
0/380
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Autoimmune arthritis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
3/189 • Number of events 3
|
0.00%
0/380
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.1%
2/189 • Number of events 2
|
1.8%
7/380 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.6%
3/189 • Number of events 3
|
0.53%
2/380 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
1.1%
2/189 • Number of events 2
|
0.79%
3/380 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.1%
2/189 • Number of events 2
|
1.1%
4/380 • Number of events 4
|
|
Nervous system disorders
Ataxia
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.53%
1/189 • Number of events 1
|
0.53%
2/380 • Number of events 2
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
Neuritis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Nervous system disorders
Seizure
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 2
|
|
Nervous system disorders
Syncope
|
1.6%
3/189 • Number of events 4
|
0.00%
0/380
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Psychiatric disorders
Delirium
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury
|
0.53%
1/189 • Number of events 1
|
1.3%
5/380 • Number of events 5
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.53%
1/189 • Number of events 1
|
0.53%
2/380 • Number of events 2
|
|
Renal and urinary disorders
Renal pain
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
2/189 • Number of events 2
|
0.53%
2/380 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.7%
24/189 • Number of events 31
|
7.6%
29/380 • Number of events 33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.53%
1/189 • Number of events 1
|
0.53%
2/380 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
6/189 • Number of events 7
|
1.6%
6/380 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.53%
1/189 • Number of events 1
|
0.26%
1/380 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
2/189 • Number of events 2
|
1.8%
7/380 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
4/189 • Number of events 7
|
0.79%
3/380 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/189
|
0.79%
3/380 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Social circumstances
Social problem
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
2/189 • Number of events 2
|
0.00%
0/380
|
|
Vascular disorders
Embolism
|
0.00%
0/189
|
0.26%
1/380 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.53%
1/189 • Number of events 1
|
0.79%
3/380 • Number of events 3
|
|
Vascular disorders
Inferior vena cava stenosis
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Vascular disorders
Inferior vena cava syndrome
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.53%
1/189 • Number of events 1
|
1.3%
5/380 • Number of events 6
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/189
|
0.79%
3/380 • Number of events 3
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/189
|
0.53%
2/380 • Number of events 3
|
|
Cardiac disorders
Acute myocardial infarction
|
0.53%
1/189 • Number of events 2
|
0.26%
1/380 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
3/189 • Number of events 3
|
1.1%
4/380 • Number of events 7
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Cardiac disorders
Cardiac failure
|
0.53%
1/189 • Number of events 1
|
0.53%
2/380 • Number of events 4
|
|
Cardiac disorders
Cardiac tamponade
|
1.1%
2/189 • Number of events 2
|
0.00%
0/380
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/189
|
0.79%
3/380 • Number of events 4
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/189
|
0.26%
1/380 • Number of events 2
|
|
Cardiac disorders
Pericardial effusion
|
3.2%
6/189 • Number of events 6
|
2.4%
9/380 • Number of events 10
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/189
|
0.79%
3/380 • Number of events 3
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Endocrine disorders
Lymphocytic hypophysitis
|
0.00%
0/189
|
0.79%
3/380 • Number of events 3
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
2/189 • Number of events 2
|
0.79%
3/380 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
4/189 • Number of events 4
|
1.8%
7/380 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Gastrointestinal disorders
Ascites
|
3.2%
6/189 • Number of events 10
|
0.79%
3/380 • Number of events 3
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/189
|
6.3%
24/380 • Number of events 27
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.53%
1/189 • Number of events 1
|
0.79%
3/380 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.53%
1/189 • Number of events 1
|
18.2%
69/380 • Number of events 106
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Gastrointestinal disorders
Faecaloma
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/189
|
0.26%
1/380 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/189
|
0.53%
2/380 • Number of events 3
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.53%
1/189 • Number of events 1
|
2.4%
9/380 • Number of events 11
|
|
Gastrointestinal disorders
Oesophageal compression
|
0.53%
1/189 • Number of events 1
|
0.00%
0/380
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/189
|
0.53%
2/380 • Number of events 2
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.00%
0/189
|
0.26%
1/380 • Number of events 1
|
Other adverse events
| Measure |
PLACEBO
n=189 participants at risk
Placebo.
|
TREMELIMUMAB
n=380 participants at risk
Tremelimumab 10mg/kg
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.2%
23/189 • Number of events 37
|
14.2%
54/380 • Number of events 76
|
|
Gastrointestinal disorders
Abdominal distension
|
6.9%
13/189 • Number of events 14
|
4.2%
16/380 • Number of events 18
|
|
Gastrointestinal disorders
Abdominal pain
|
11.6%
22/189 • Number of events 31
|
11.6%
44/380 • Number of events 54
|
|
Gastrointestinal disorders
Constipation
|
28.0%
53/189 • Number of events 62
|
17.1%
65/380 • Number of events 82
|
|
Gastrointestinal disorders
Diarrhoea
|
18.5%
35/189 • Number of events 49
|
44.2%
168/380 • Number of events 368
|
|
Gastrointestinal disorders
Nausea
|
20.1%
38/189 • Number of events 50
|
27.1%
103/380 • Number of events 126
|
|
Gastrointestinal disorders
Vomiting
|
8.5%
16/189 • Number of events 17
|
18.7%
71/380 • Number of events 91
|
|
General disorders
Asthenia
|
12.7%
24/189 • Number of events 28
|
13.7%
52/380 • Number of events 75
|
|
General disorders
Fatigue
|
31.7%
60/189 • Number of events 72
|
23.9%
91/380 • Number of events 119
|
|
General disorders
Non-cardiac chest pain
|
5.3%
10/189 • Number of events 13
|
4.5%
17/380 • Number of events 21
|
|
General disorders
Oedema peripheral
|
8.5%
16/189 • Number of events 16
|
10.3%
39/380 • Number of events 45
|
|
General disorders
Pyrexia
|
8.5%
16/189 • Number of events 18
|
13.9%
53/380 • Number of events 81
|
|
Infections and infestations
Urinary tract infection
|
2.1%
4/189 • Number of events 5
|
5.5%
21/380 • Number of events 24
|
|
Investigations
Weight decreased
|
9.0%
17/189 • Number of events 18
|
12.4%
47/380 • Number of events 54
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.8%
45/189 • Number of events 52
|
28.9%
110/380 • Number of events 139
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
2/189 • Number of events 2
|
5.5%
21/380 • Number of events 21
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.6%
5/189 • Number of events 8
|
6.6%
25/380 • Number of events 33
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
18/189 • Number of events 18
|
5.5%
21/380 • Number of events 24
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
17.5%
33/189 • Number of events 41
|
12.4%
47/380 • Number of events 64
|
|
Nervous system disorders
Headache
|
3.2%
6/189 • Number of events 8
|
5.3%
20/380 • Number of events 23
|
|
Psychiatric disorders
Anxiety
|
6.9%
13/189 • Number of events 13
|
5.3%
20/380 • Number of events 20
|
|
Psychiatric disorders
Insomnia
|
6.9%
13/189 • Number of events 13
|
7.6%
29/380 • Number of events 30
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.3%
29/189 • Number of events 34
|
17.4%
66/380 • Number of events 83
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
31.7%
60/189 • Number of events 79
|
27.1%
103/380 • Number of events 127
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.3%
10/189 • Number of events 15
|
4.5%
17/380 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.3%
10/189 • Number of events 10
|
3.4%
13/380 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.9%
15/189 • Number of events 19
|
27.1%
103/380 • Number of events 157
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.4%
14/189 • Number of events 16
|
20.0%
76/380 • Number of events 113
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the communication of results, it being understood that results shall be published regardless of outcome
- Publication restrictions are in place
Restriction type: OTHER