Trial Outcomes & Findings for SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (NCT NCT02455557)

Last Updated: 2025-10-10

Results Overview

The 6-month progression-free survival (PFS6) estimated using the Kaplan-Meier methods. PFS6 is defined as the percentage of patients without tumor progression or death from any cause 6 months after the date of diagnosis by biopsy. Corresponding confidence intervals will be computed.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

66 participants

Primary outcome timeframe

Date of diagnosis to the date of first observed disease progression or death due to any cause, assessed at 6 months

Results posted on

2025-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (SurVaxM, Temozolomide) Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Montanide ISA 51 VG: Given SC Sargramostim: Given SC SVN53-67/M57-KLH Peptide Vaccine: Given SC Temozolomide: Given PO or IV
Overall Study STARTED	66
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (SurVaxM, Temozolomide) Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Montanide ISA 51 VG: Given SC Sargramostim: Given SC SVN53-67/M57-KLH Peptide Vaccine: Given SC Temozolomide: Given PO or IV
Overall Study Withdrawal by Subject	2

Baseline Characteristics

SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (SurVaxM, Temozolomide) n=66 Participants Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Montanide ISA 51 VG: Given SC Sargramostim: Given SC SVN53-67/M57-KLH Peptide Vaccine: Given SC Temozolomide: Given PO or IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Age, Continuous	56.8 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	39 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	1 Participants n=5 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Date of diagnosis to the date of first observed disease progression or death due to any cause, assessed at 6 months

Population: All treated and eligible patients that completed the priming dose

Outcome measures

Outcome measures
Measure	Treatment (SurVaxM, Temozolomide) n=64 Participants Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Montanide ISA 51 VG: Given SC Sargramostim: Given SC SVN53-67/M57-KLH Peptide Vaccine: Given SC Temozolomide: Given PO or IV
Progression-free Survival (PFS)	95 percentage of participants Interval 86.0 to 98.0

SECONDARY outcome

Timeframe: Up to 30 days after completion of study treatment

A series of exploratory analyses will initially take place including individual subject-level profile plots and overall mean plots used to examining the mean structure. Formal statistical examination of longitudinal patterns will be done through the use of a mixed model. Restricted maximum likelihood estimation will be utilized in the model fitting procedures. Once the model is fit, specific linear contrasts based on the estimated model parameters will be constructed and used to test hypotheses concerning between time point comparisons.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days after completion of study treatment

Population: All treated and eligible patients

Toxicities will be summarized using simple frequencies by grade. CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows: Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.

Outcome measures

Outcome measures
Measure	Treatment (SurVaxM, Temozolomide) n=66 Participants Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Montanide ISA 51 VG: Given SC Sargramostim: Given SC SVN53-67/M57-KLH Peptide Vaccine: Given SC Temozolomide: Given PO or IV
Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4 Grade 1	13 Participants
Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4 Grade 2	20 Participants
Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4 Grade 3	29 Participants
Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4 Grade 4	3 Participants
Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4 Grade 5	1 Participants

SECONDARY outcome

Timeframe: Date of diagnosis until (1) date of death or (2) the last date patient known alive (if death is not observed), assessed up to 2 years

Population: All treated and eligible patients that completed priming dose

The median overall survival estimated using the Kaplan-Meier methods. Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals will be computed.

Outcome measures

Outcome measures
Measure	Treatment (SurVaxM, Temozolomide) n=64 Participants Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Montanide ISA 51 VG: Given SC Sargramostim: Given SC SVN53-67/M57-KLH Peptide Vaccine: Given SC Temozolomide: Given PO or IV
Overall Survival	25.8 months Interval 19.5 to 43.5

Adverse Events

Treatment (SurVaxM, Temozolomide)

Serious events: 22 serious events

Other events: 65 other events

Deaths: 36 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (SurVaxM, Temozolomide) n=66 participants at risk Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Montanide ISA 51 VG: Given SC Sargramostim: Given SC SVN53-67/M57-KLH Peptide Vaccine: Given SC Temozolomide: Given PO or IV
Gastrointestinal disorders Enterovesical fistula	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Fatigue	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Gait disturbance	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Influenza like illness	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Injection site reaction	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Oedema peripheral	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Pyrexia	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Infections and infestations Bronchitis	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Infections and infestations Colonic abscess	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Infections and infestations Influenza	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Infections and infestations Meningitis aseptic	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Injury, poisoning and procedural complications Fall	4.5% 3/66 • Number of events 3 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Injury, poisoning and procedural complications Hip fracture	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Injury, poisoning and procedural complications Wound complication	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Injury, poisoning and procedural complications Wound dehiscence	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Aphasia	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Cerebrovascular accident	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Dizziness	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Dysarthria	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Haemorrhage intracranial	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Hemiparesis	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Paraesthesia	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Seizure	4.5% 3/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Confusional state	7.6% 5/66 • Number of events 6 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Respiratory, thoracic and mediastinal disorders Haemothorax	1.5% 1/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Respiratory, thoracic and mediastinal disorders Pleurisy	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Surgical and medical procedures Chest tube insertion	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Surgical and medical procedures Craniotomy	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Surgical and medical procedures Hip surgery	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Surgical and medical procedures Thoracotomy	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Vascular disorders Deep vein thrombosis	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Vascular disorders Haematoma	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.

Other adverse events

Other adverse events
Measure	Treatment (SurVaxM, Temozolomide) n=66 participants at risk Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Montanide ISA 51 VG: Given SC Sargramostim: Given SC SVN53-67/M57-KLH Peptide Vaccine: Given SC Temozolomide: Given PO or IV
Nervous system disorders Syncope	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Taste disorder	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Tremor	1.5% 1/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Affect lability	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Agitation	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Anxiety	6.1% 4/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Confusional state	9.1% 6/66 • Number of events 6 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Depression	4.5% 3/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Dysphoria	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Hallucination	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Hallucination, visual	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Insomnia	4.5% 3/66 • Number of events 3 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Libido decreased	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Mental disorder	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Sleep disorder	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Psychiatric disorders Suicidal ideation	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Renal and urinary disorders Haematuria	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Renal and urinary disorders Incontinence	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Renal and urinary disorders Proteinuria	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Respiratory, thoracic and mediastinal disorders Cough	10.6% 7/66 • Number of events 8 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.1% 4/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Respiratory, thoracic and mediastinal disorders Sinus congestion	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Respiratory, thoracic and mediastinal disorders Sinus pain	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Respiratory, thoracic and mediastinal disorders Wheezing	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Alopecia	4.5% 3/66 • Number of events 3 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Dermatitis acneiform	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Dry skin	4.5% 3/66 • Number of events 3 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Erythema	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Pain of skin	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Panniculitis	3.0% 2/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Pruritus	6.1% 4/66 • Number of events 6 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Rash	12.1% 8/66 • Number of events 13 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Skin disorder	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Skin hypertrophy	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Skin induration	7.6% 5/66 • Number of events 5 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Skin lesion	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Skin mass	6.1% 4/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Skin and subcutaneous tissue disorders Urticaria	4.5% 3/66 • Number of events 5 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Surgical and medical procedures Rotator cuff repair	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Vascular disorders Hypertension	6.1% 4/66 • Number of events 6 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Vascular disorders Hypotension	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Vascular disorders Peripheral coldness	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Blood and lymphatic system disorders Anaemia	18.2% 12/66 • Number of events 41 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Blood and lymphatic system disorders Thrombocytopenia	6.1% 4/66 • Number of events 7 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Cardiac disorders Angina pectoris	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Cardiac disorders Atrial fibrillation	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Cardiac disorders Bradycardia	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Cardiac disorders Tachycardia	4.5% 3/66 • Number of events 9 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Ear and labyrinth disorders Deafness	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Ear and labyrinth disorders Excessive cerumen production	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Ear and labyrinth disorders Hypoacusis	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Ear and labyrinth disorders Tinnitus	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Ear and labyrinth disorders Vertigo	6.1% 4/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Endocrine disorders Cushingoid	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Endocrine disorders Hypothyroidism	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Eye disorders Cataract	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Eye disorders Eye pain	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Eye disorders Visual impairment	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Gastrointestinal disorders Abdominal pain	1.5% 1/66 • Number of events 3 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Gastrointestinal disorders Constipation	27.3% 18/66 • Number of events 20 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Gastrointestinal disorders Diarrhoea	7.6% 5/66 • Number of events 8 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Gastrointestinal disorders Dry mouth	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Gastrointestinal disorders Dysphagia	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Gastrointestinal disorders Flatulence	1.5% 1/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Gastrointestinal disorders Gastritis	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Gastrointestinal disorders Nausea	47.0% 31/66 • Number of events 48 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Gastrointestinal disorders Oesophageal spasm	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Gastrointestinal disorders Retching	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Gastrointestinal disorders Vomiting	15.2% 10/66 • Number of events 21 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Application site discolouration	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Asthenia	7.6% 5/66 • Number of events 5 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Chills	3.0% 2/66 • Number of events 3 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Cyst	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Face oedema	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Fatigue	45.5% 30/66 • Number of events 45 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Gait disturbance	6.1% 4/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Implant site oedema	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Influenza like illness	4.5% 3/66 • Number of events 8 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Injection site bruising	6.1% 4/66 • Number of events 5 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Injection site discharge	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Injection site erythema	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Injection site induration	4.5% 3/66 • Number of events 6 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Injection site inflammation	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Injection site nodule	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Injection site pain	13.6% 9/66 • Number of events 14 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Injection site pruritus	6.1% 4/66 • Number of events 5 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Injection site rash	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Injection site reaction	40.9% 27/66 • Number of events 65 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Injection site swelling	4.5% 3/66 • Number of events 3 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Malaise	3.0% 2/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Mucosal inflammation	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Non-cardiac chest pain	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Oedema peripheral	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Pain	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Peripheral swelling	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
General disorders Pyrexia	9.1% 6/66 • Number of events 10 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Immune system disorders Hypersensitivity	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Infections and infestations Bronchitis	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Infections and infestations Influenza	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Infections and infestations Injection site infection	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Infections and infestations Lyme disease	1.5% 1/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Infections and infestations Respiratory tract infection	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Infections and infestations Skin infection	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Infections and infestations Tooth infection	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Infections and infestations Upper respiratory tract infection	10.6% 7/66 • Number of events 8 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Infections and infestations Urinary tract infection	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Injury, poisoning and procedural complications Fall	9.1% 6/66 • Number of events 7 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Injury, poisoning and procedural complications Incision site complication	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Injury, poisoning and procedural complications Spinal compression fracture	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Injury, poisoning and procedural complications Wound complication	1.5% 1/66 • Number of events 3 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Alanine aminotransferase increased	7.6% 5/66 • Number of events 7 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Aspartate aminotransferase increased	7.6% 5/66 • Number of events 7 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Blood alkaline phosphatase increased	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Blood bilirubin increased	6.1% 4/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Blood cholesterol increased	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Blood creatinine increased	1.5% 1/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Blood glucose increased	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Blood ketone body	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Haemoglobin urine present	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Lymphocyte count decreased	31.8% 21/66 • Number of events 92 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Neutrophil count decreased	22.7% 15/66 • Number of events 55 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Neutrophil count increased	6.1% 4/66 • Number of events 10 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Platelet count decreased	37.9% 25/66 • Number of events 66 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Transaminases increased	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Urine ketone body present	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Weight decreased	4.5% 3/66 • Number of events 3 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations Weight increased	1.5% 1/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations White blood cell count decreased	31.8% 21/66 • Number of events 103 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Investigations White blood cell count increased	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Metabolism and nutrition disorders Decreased appetite	27.3% 18/66 • Number of events 22 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Metabolism and nutrition disorders Gout	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Metabolism and nutrition disorders Hyperglycaemia	18.2% 12/66 • Number of events 15 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Metabolism and nutrition disorders Hyperkalaemia	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Metabolism and nutrition disorders Hypernatraemia	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Metabolism and nutrition disorders Hypoalbuminaemia	4.5% 3/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Metabolism and nutrition disorders Hypocalcaemia	4.5% 3/66 • Number of events 5 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Metabolism and nutrition disorders Hypoglycaemia	1.5% 1/66 • Number of events 3 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Metabolism and nutrition disorders Hypokalaemia	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Metabolism and nutrition disorders Hyponatraemia	7.6% 5/66 • Number of events 5 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Metabolism and nutrition disorders Obesity	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 6/66 • Number of events 6 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Back pain	6.1% 4/66 • Number of events 5 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Costochondritis	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Fasciitis	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Groin pain	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Limb discomfort	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Muscle discomfort	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Muscle spasms	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Muscular weakness	6.1% 4/66 • Number of events 8 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.5% 3/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Myalgia	9.1% 6/66 • Number of events 7 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Neck pain	6.1% 4/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Pain in extremity	6.1% 4/66 • Number of events 5 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Musculoskeletal and connective tissue disorders Pain in jaw	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Amnesia	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Aphasia	7.6% 5/66 • Number of events 6 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Ataxia	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Balance disorder	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Cerebrospinal fluid leakage	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Cerebrovascular accident	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Cognitive disorder	6.1% 4/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Coordination abnormal	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Depressed level of consciousness	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Dizziness	13.6% 9/66 • Number of events 14 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Dysgeusia	4.5% 3/66 • Number of events 4 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Headache	30.3% 20/66 • Number of events 25 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Hemiparesis	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Memory impairment	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Mental impairment	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Neuralgia	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Paraesthesia	7.6% 5/66 • Number of events 6 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Partial seizures	1.5% 1/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Presyncope	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Sciatica	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Seizure	16.7% 11/66 • Number of events 12 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Seizure like phenomena	3.0% 2/66 • Number of events 2 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.
Nervous system disorders Sinus headache	1.5% 1/66 • Number of events 1 • Start date of intervention until 30 days after the last intervention or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported.

Additional Information

Senior Administrator, Compliance - Clinical Research Services

Roswell Park Cancer Institute

Phone: 716-845-2300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place