Trial Outcomes & Findings for Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases (NCT NCT04789668)

Last Updated: 2026-03-18

Results Overview

Establish safety profile and recommended phase II dose for combining pimasertib with bintrafusp alfa (M7824) in patients with brain metastases.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2026-03-18

Participant Flow

8 subjects treated. The study was closed early and did not proceed to phase II due to sponsor decision.

Participant milestones

Participant milestones
Measure	Dose Level 1 Bintrafusp Alfa (M7824) 1200 mg IV q 2 wks \& Pimasertib 45 mg Orally BID	Dose-Level 2 Bintrafusp Alfa (M7824) 1200 mg IV q 2 wks \& Pimasertib 60 mg Orally BID
Overall Study STARTED	4	4
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 n=4 Participants Bintrafusp Alfa 1200mg q 2 weeks \& Pimasertib 45 mg orally BID	Dose-Level 2 n=4 Participants Bintrafusp Alfa 1200mg q 2 weeks \& Pimasertib 60 mg orally BID	Phase II Did not proceed due to sponsor decision	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=110 Participants	0 Participants n=114 Participants	—	0 Participants n=104 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=110 Participants	2 Participants n=114 Participants	—	5 Participants n=104 Participants
Age, Categorical >=65 years	1 Participants n=110 Participants	2 Participants n=114 Participants	—	3 Participants n=104 Participants
Sex: Female, Male Female	2 Participants n=110 Participants	2 Participants n=114 Participants	—	4 Participants n=104 Participants
Sex: Female, Male Male	2 Participants n=110 Participants	2 Participants n=114 Participants	—	4 Participants n=104 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=110 Participants	0 Participants n=114 Participants	—	0 Participants n=104 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=110 Participants	4 Participants n=114 Participants	—	8 Participants n=104 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=110 Participants	0 Participants n=114 Participants	—	0 Participants n=104 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=110 Participants	0 Participants n=114 Participants	—	0 Participants n=104 Participants
Race (NIH/OMB) Asian	0 Participants n=110 Participants	0 Participants n=114 Participants	—	0 Participants n=104 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=110 Participants	0 Participants n=114 Participants	—	0 Participants n=104 Participants
Race (NIH/OMB) Black or African American	0 Participants n=110 Participants	0 Participants n=114 Participants	—	0 Participants n=104 Participants
Race (NIH/OMB) White	4 Participants n=110 Participants	4 Participants n=114 Participants	—	8 Participants n=104 Participants
Race (NIH/OMB) More than one race	0 Participants n=110 Participants	0 Participants n=114 Participants	—	0 Participants n=104 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=110 Participants	0 Participants n=114 Participants	—	0 Participants n=104 Participants
Region of Enrollment United States	4 participants n=110 Participants	4 participants n=114 Participants	—	8 participants n=104 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: The study was closed by the industry sponsor and a phase II recommended dose was not reached.

Establish safety profile and recommended phase II dose for combining pimasertib with bintrafusp alfa (M7824) in patients with brain metastases.

Outcome measures

Outcome measures
Measure	Dose-Level n=8 Participants Bintrafusp Alfa 1200 mg IV q 2 weeks \& Pimasertib 45 or 60 mg orally BID	Phase II Did not proceed due to sponsor decision	Phase II Did not proceed due to Sponsor decision.
Phase I - Determine Phase II Dose Grade 3-4 toxicities, regardless of drug attribution	8 Participants	—	—
Phase I - Determine Phase II Dose Treatment related grade 3-4 toxicities	2 Participants	—	—
Phase I - Determine Phase II Dose DLTs	6 Participants	—	—

PRIMARY outcome

Timeframe: Baseline up to 2 years

Population: The study was closed early and did not proceed to phase II due to sponsor decision.

Time to intracranial progression (defined as progression of existing lesions and development of new lesions by modified RECIST 1.1) and Overall survival

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 18 months

Population: 1 patient not evaluable

Kaplan Meier estimation with 95% confidence interval

Outcome measures

Outcome measures
Measure	Dose-Level n=4 Participants Bintrafusp Alfa 1200 mg IV q 2 weeks \& Pimasertib 45 or 60 mg orally BID	Phase II n=3 Participants Did not proceed due to sponsor decision	Phase II Did not proceed due to Sponsor decision.
Intracranial Progression Free Survival	9.7 weeks Interval 4.14 to 30.29	9.7 weeks Interval 4.14 to 30.29	—

SECONDARY outcome

Timeframe: From treatment start date to death, assessed up to 2 years

Population: Phase II did not proceed due to Sponsor decision

Outcome measures

Outcome measures
Measure	Dose-Level n=4 Participants Bintrafusp Alfa 1200 mg IV q 2 weeks \& Pimasertib 45 or 60 mg orally BID	Phase II n=4 Participants Did not proceed due to sponsor decision	Phase II Did not proceed due to Sponsor decision.
Overall Survival	28.9 weeks Interval 16.29 to 61.0	28.9 weeks Interval 16.29 to 61.0	—

SECONDARY outcome

Timeframe: From the time of study enrollment to intracranial progression (event) or the last follow-up date if the patient has not developed the intracranial progression yet

Population: Only 1 participant had a post progression scan. The prespecified analysis in the protocol requires estimation of median time to secondary progression using Kaplan-Meier methods with a 95% CI. The ClinicalTrials.gov reporting also requires prespecified summary statistic (Median, 95% CI), which also cannot be estimated with a single observation. Therefore, the singular datapoint is not analyzable and values are reported as NA. The Analysis Population Description has been revised accordingly.

Determined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and estimated using Kaplan-Meier method with 95% confidence interval.

Outcome measures

Outcome measures
Measure	Dose-Level Bintrafusp Alfa 1200 mg IV q 2 weeks \& Pimasertib 45 or 60 mg orally BID	Phase II n=1 Participants Did not proceed due to sponsor decision	Phase II Did not proceed due to Sponsor decision.
Time to Second Intracranial Progression	—	NA weeks The time to secondary progression cannot be evaluated due to the early hanging of the trial and the inability to perform the stated statistical analyses. Only 1 patient had subsequent scans to evaluate the endpoint. However, the statistical plan requires more than one patient to perform a KM median with a 95% CI.	—

SECONDARY outcome

Timeframe: baseline to 1 year

Population: Phase II did not proceed due to Sponsor decision

Will record and report steroid requirements for symptom management overall and within each treatment group. Patients who require at least 4 mg of dexamethasone/day for symptom management will be considered as requiring high dose steroids.

Outcome measures

Outcome measures
Measure	Dose-Level n=4 Participants Bintrafusp Alfa 1200 mg IV q 2 weeks \& Pimasertib 45 or 60 mg orally BID	Phase II n=4 Participants Did not proceed due to sponsor decision	Phase II Did not proceed due to Sponsor decision.
Dose, Duration and Frequency of Steroid Use for Symptomatic Management 4 mg of dexamethasone/day	0 Participants	0 Participants	—
Dose, Duration and Frequency of Steroid Use for Symptomatic Management 2 mg of dexamethasone/day	0 Participants	1 Participants	—

Adverse Events

Dose-Level 1

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

Dose-Level 2

Serious events: 2 serious events

Other events: 4 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Dose-Level 1 n=4 participants at risk Bintrafusp 1200 mg (flat dose) IV over 1 hr q2 wks \& Pimasertib 45 mg Orally BID	Dose-Level 2 n=4 participants at risk Bintrafusp 1200 mg (flat dose) IV over 1 hr q2 wks \& Pimaserib 60 mg Orally BID
Blood and lymphatic system disorders Anemia	25.0% 1/4 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Gastrointestinal disorders Abdominal Distention	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Baseline to 2 years No deaths were reported for this study.
Nervous system disorders Cauda Equina	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Baseline to 2 years No deaths were reported for this study.
Nervous system disorders Intracranial Hemmorhage	25.0% 1/4 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Renal and urinary disorders Kidney Infection	25.0% 1/4 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Respiratory, thoracic and mediastinal disorders Lung Infection	25.0% 1/4 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Skin and subcutaneous tissue disorders Dress Drug Reaction	25.0% 1/4 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Vascular disorders Thromboembolic Event	25.0% 1/4 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.

Other adverse events

Additional Information

Dr. Hussein Tawbi

The University of Texas MD Anderson Cancer Center

Phone: (713) 792-4185

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Dose-Level 1 n=4 participants at risk Bintrafusp 1200 mg (flat dose) IV over 1 hr q2 wks \& Pimasertib 45 mg Orally BID	Dose-Level 2 n=4 participants at risk Bintrafusp 1200 mg (flat dose) IV over 1 hr q2 wks \& Pimaserib 60 mg Orally BID
Gastrointestinal disorders Constipation	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Investigations CPK	75.0% 3/4 • Number of events 11 • Baseline to 2 years No deaths were reported for this study.	50.0% 2/4 • Number of events 3 • Baseline to 2 years No deaths were reported for this study.
Investigations Creatinine increased	50.0% 2/4 • Number of events 7 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Gastrointestinal disorders Diarrhea	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.	75.0% 3/4 • Number of events 3 • Baseline to 2 years No deaths were reported for this study.
Nervous system disorders Dizziness	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Eye disorders Dry Eye	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Nervous system disorders Dysarthria	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Nervous system disorders Dysgeusia	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 2/4 • Number of events 4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
General disorders Edema Face	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
General disorders Edema limbs	50.0% 2/4 • Number of events 5 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Gastrointestinal disorders Abdominal Distension	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Gastrointestinal disorders Abdominal Pain	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.
Investigations Alanine aminotransderase increased	75.0% 3/4 • Number of events 3 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Investigations Alkaline phosphatas increased	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Skin and subcutaneous tissue disorders Alopecia	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Blood and lymphatic system disorders Anemia	75.0% 3/4 • Number of events 11 • Baseline to 2 years No deaths were reported for this study.	100.0% 4/4 • Number of events 10 • Baseline to 2 years No deaths were reported for this study.
Metabolism and nutrition disorders Anorexia	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Gastrointestinal disorders Ascites	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Investigations Aspartate aminotransferase increased	50.0% 2/4 • Number of events 4 • Baseline to 2 years No deaths were reported for this study.	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.
Investigations Blood lactate dehydrogenase increased	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.
Eye disorders Blurred vision	50.0% 2/4 • Number of events 3 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Injury, poisoning and procedural complications Bruising	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
General disorders Chills	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Gastrointestinal disorders colitis	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Psychiatric disorders Confusion	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Respiratory, thoracic and mediastinal disorders Epistaxis	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Eye disorders Eye pain	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Nervous system disorders Facial muscle weakness	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Injury, poisoning and procedural complications Fall	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
General disorders Fatigue	75.0% 3/4 • Number of events 3 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 3 • Baseline to 2 years No deaths were reported for this study.
Gastrointestinal disorders Fecal incontinence	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
General disorders Fever	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Eye disorders Floaters	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Injury, poisoning and procedural complications Fracture	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
General disorders Gait disturbance	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Gastrointestinal disorders Gastroesophageal reflux disease	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
General disorders Genrealized edema	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Renal and urinary disorders Hematuria	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Metabolism and nutrition disorders Hypercalcemia	25.0% 1/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Metabolism and nutrition disorders Hyperphosphatemia	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	75.0% 3/4 • Number of events 3 • Baseline to 2 years No deaths were reported for this study.
Metabolism and nutrition disorders Hypocalmeia	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Metabolism and nutrition disorders Hypoglycemia	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Metabolism and nutrition disorders Hyponatremia	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Metabolism and nutrition disorders Hypophosphatemia	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Investigations INR increased	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Psychiatric disorders Insomnia	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
General disorders Localized edema	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Investigations Lymphoccyte count decreased	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
General disorders Malaise	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Gastrointestinal disorders Mucositis oral	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Gastrointestinal disorders Nausea	50.0% 2/4 • Number of events 3 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Musculoskeletal and connective tissue disorders Neck pain	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Eye disorders Papilledema	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Infections and infestations Papulopustular rash	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Nervous system disorders Paresthesia	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Infections and infestations Paronchia	25.0% 1/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Eye disorders Periorbital edema	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Nervous system disorders Peripheral motor neuropathy	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Skin and subcutaneous tissue disorders Photosensitivity	25.0% 1/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Investigations Platelet count decreased	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.
Respiratory, thoracic and mediastinal disorders Productive cough	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Renal and urinary disorders Proteinuria	100.0% 4/4 • Number of events 6 • Baseline to 2 years No deaths were reported for this study.	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.
Skin and subcutaneous tissue disorders Pruritus	50.0% 2/4 • Number of events 4 • Baseline to 2 years No deaths were reported for this study.	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.
Skin and subcutaneous tissue disorders Rash acneiform	75.0% 3/4 • Number of events 10 • Baseline to 2 years No deaths were reported for this study.	75.0% 3/4 • Number of events 4 • Baseline to 2 years No deaths were reported for this study.
Eye disorders Retinopathy	25.0% 1/4 • Number of events 3 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Skin and subcutaneous tissue disorders Skin infection	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Nervous system disorders Syncope	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Investigations Thyroid stimulating hormone increased	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Renal and urinary disorders Urinary incontinence	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Infections and infestations Urinary tract infection	25.0% 1/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Renal and urinary disorders Urinary urgency	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.
Eye disorders Uveitis	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.
Gastrointestinal disorders Vomiting	75.0% 3/4 • Number of events 6 • Baseline to 2 years No deaths were reported for this study.	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.
Investigations White blood cell decreased	25.0% 1/4 • Number of events 1 • Baseline to 2 years No deaths were reported for this study.	75.0% 3/4 • Number of events 3 • Baseline to 2 years No deaths were reported for this study.
Blood and lymphatic system disorders Thrombocytosis	50.0% 2/4 • Number of events 2 • Baseline to 2 years No deaths were reported for this study.	0.00% 0/4 • Baseline to 2 years No deaths were reported for this study.