Trial Outcomes & Findings for A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors (NCT NCT05661578)
NCT ID: NCT05661578
Last Updated: 2026-06-18
Results Overview
An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention.
COMPLETED
PHASE2
64 participants
Up to approximately 30.5 months
2026-06-18
Participant Flow
A total of 64 adult participants with histologically-confirmed programmed death-ligand 1 (PD-L1)-selected locally advanced, recurrent, or metastatic solid tumors, took part in the study at 27 investigative sites across 8 countries from 04 May 2023 to 26 December 2025.
Participants received a fixed dose combination (FDC) of tiragolumab and atezolizumab. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.
Participant milestones
| Measure |
Atezolizumab + Tiragolumab FDC
Participants received FDC of tiragolumab , 600 milligrams (mg) and atezolizumab , 1200 mg, as intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression (PD) per investigator-assessed Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
Safety Analysis Set (SAS)
|
63
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
64
|
Reasons for withdrawal
| Measure |
Atezolizumab + Tiragolumab FDC
Participants received FDC of tiragolumab , 600 milligrams (mg) and atezolizumab , 1200 mg, as intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression (PD) per investigator-assessed Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
Overall Study
Death
|
33
|
|
Overall Study
Reason not Specified
|
1
|
|
Overall Study
Study Ended by Sponsor
|
26
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
Atezolizumab + Tiragolumab FDC
n=64 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 9.1 • n=20 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 30.5 monthsPopulation: SAS included all participants who received any amount of study treatment.
An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention.
Outcome measures
| Measure |
Atezolizumab + Tiragolumab FDC
n=63 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
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|---|---|
|
Number of Participants With Adverse Events (AEs)
|
59 Participants
|
SECONDARY outcome
Timeframe: Up to Day 21 of Cycle 1 (1 cycle=21 days)Population: Tiragolumab pharmacokinetic (PK)-evaluable set included all participants who received any amount of tiragolumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis.
day\*µg/mL=day-micrograms per milliliter.
Outcome measures
| Measure |
Atezolizumab + Tiragolumab FDC
n=53 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
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|---|---|
|
Area Under the Concentration-time Curve From 0 to 21 Days (AUC0-21d) of Tiragolumab at Cycle 1
|
1470 day*µg/mL
Geometric Coefficient of Variation 24.7
|
SECONDARY outcome
Timeframe: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)Population: Tiragolumab PK-evaluable set included all participants who received any amount of tiragolumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Atezolizumab + Tiragolumab FDC
n=52 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
Area Under the Serum Concentration Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tiragolumab at Cycle 1
|
2010 day*µg/mL
Geometric Coefficient of Variation 34.6
|
SECONDARY outcome
Timeframe: Up to Day 21 of Cycle 1 (1 cycle=21 days)Population: Atezolizumab PK-evaluable set included all participants who received any amount of atezolizumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Atezolizumab + Tiragolumab FDC
n=49 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
AUC0-21d of Atezolizumab at Cycle 1
|
2590 day*µg/mL
Geometric Coefficient of Variation 20.3
|
SECONDARY outcome
Timeframe: 30 minutes post-dose Day 1 of Cycle 1 (1 cycle=21 days)Population: Atezolizumab PK-evaluable set included all participants who received any amount of atezolizumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Atezolizumab + Tiragolumab FDC
n=46 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
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|---|---|
|
AUC0-inf of Atezolizumab at Cycle 1
|
3580 day*µg/mL
Geometric Coefficient of Variation 28.0
|
SECONDARY outcome
Timeframe: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)Population: Tiragolumab PK-evaluable set included all participants who received any amount of tiragolumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Atezolizumab + Tiragolumab FDC
n=55 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
Maximum Concentration (Cmax) of Tiragolumab at Cycle 1
|
206 µg/mL (micrograms per milliliter)
Geometric Coefficient of Variation 22.1
|
SECONDARY outcome
Timeframe: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)Population: Atezolizumab PK-evaluable set included all participants who received any amount of atezolizumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Atezolizumab + Tiragolumab FDC
n=51 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
Cmax of Atezolizumab at Cycle 1
|
336 µg/mL
Geometric Coefficient of Variation 19.2
|
SECONDARY outcome
Timeframe: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)Population: Tiragolumab PK-evaluable set included all participants who received any amount of tiragolumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Atezolizumab + Tiragolumab FDC
n=48 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
Minimum Concentration (Cmin) of Tiragolumab at Cycle 1
|
30.8 µg/mL
Geometric Coefficient of Variation 39.5
|
SECONDARY outcome
Timeframe: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)Population: Atezolizumab PK-evaluable set included all participants who received any amount of atezolizumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Atezolizumab + Tiragolumab FDC
n=48 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
Cmin of Atezolizumab at Cycle 1
|
60.2 µg/mL
Geometric Coefficient of Variation 31.1
|
SECONDARY outcome
Timeframe: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)Population: Tiragolumab PK-evaluable set included all participants who received any amount of tiragolumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Atezolizumab + Tiragolumab FDC
n=52 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
Total Body Clearance (CL) of Tiragolumab at Cycle 1
|
0.299 liters/day (L/day)
Geometric Coefficient of Variation 34.6
|
SECONDARY outcome
Timeframe: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)Population: Atezolizumab PK-evaluable set included all participants who received any amount of atezolizumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Atezolizumab + Tiragolumab FDC
n=46 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
CL of Atezolizumab at Cycle 1
|
0.336 L/day
Geometric Coefficient of Variation 28.0
|
SECONDARY outcome
Timeframe: Up to approximately 14.9 monthsPopulation: SAS included all participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis.
Participants were considered to be treatment-emergent ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.
Outcome measures
| Measure |
Atezolizumab + Tiragolumab FDC
n=57 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 14.9 monthsPopulation: SAS included all participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis.
Participants were considered to be treatment-emergent ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.
Outcome measures
| Measure |
Atezolizumab + Tiragolumab FDC
n=57 Participants
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
Number of Participants With ADAs to Atezolizumab
|
22 Participants
|
Adverse Events
Atezolizumab + Tiragolumab FDC
Serious adverse events
| Measure |
Atezolizumab + Tiragolumab FDC
n=63 participants at risk
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
3.2%
2/63 • Number of events 2 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Subileus
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
General disorders
Death
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
General disorders
Swelling
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
General disorders
Systemic inflammatory response syndrome
|
3.2%
2/63 • Number of events 2 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Infections and infestations
Bacteraemia
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Infections and infestations
Bacterial infection
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Infections and infestations
Biliary tract infection
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Infections and infestations
COVID-19
|
3.2%
2/63 • Number of events 2 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Infections and infestations
Cytomegalovirus infection
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Infections and infestations
Device related infection
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Infections and infestations
Fungaemia
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Infections and infestations
Pneumonia
|
3.2%
2/63 • Number of events 2 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Infections and infestations
Urosepsis
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Investigations
Blood creatinine increased
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Investigations
Weight decreased
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Demyelination
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Neurotoxicity
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Delirium
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Vascular disorders
Arterial thrombosis
|
1.6%
1/63 • Number of events 1 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
Other adverse events
| Measure |
Atezolizumab + Tiragolumab FDC
n=63 participants at risk
Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.6%
13/63 • Number of events 18 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.7%
8/63 • Number of events 10 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
14/63 • Number of events 20 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
7.9%
5/63 • Number of events 6 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
7.9%
5/63 • Number of events 6 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.3%
4/63 • Number of events 4 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
General disorders
Fatigue
|
19.0%
12/63 • Number of events 14 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
General disorders
Pyrexia
|
6.3%
4/63 • Number of events 5 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.9%
5/63 • Number of events 5 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
6.3%
4/63 • Number of events 4 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
7.9%
5/63 • Number of events 6 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Investigations
Blood bilirubin increased
|
6.3%
4/63 • Number of events 7 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Investigations
Weight decreased
|
7.9%
5/63 • Number of events 5 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.7%
8/63 • Number of events 11 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.9%
5/63 • Number of events 8 • Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER