Trial Outcomes & Findings for Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (NCT NCT00026312)

NCT ID: NCT00026312

Last Updated: 2025-11-24

Results Overview

Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 1449 participants
• Primary outcome timeframe: Three years
• Results posted on: 2025-11-24

Participant Flow

Participant milestones

Measure	Regimen A Randomized to Regimen A - RA Only	Regimen B Regimen B - RA + Immunotherapy
Overall Study STARTED	116	1333
Overall Study COMPLETED	82	1064
Overall Study NOT COMPLETED	34	269

Reasons for withdrawal

Measure	Regimen A Randomized to Regimen A - RA Only	Regimen B Regimen B - RA + Immunotherapy
Overall Study Adverse Event	0	32
Overall Study Death	1	7
Overall Study Lack of Efficacy	19	114
Overall Study Lost to Follow-up	0	5
Overall Study Physician Decision	1	37
Overall Study Protocol Violation	0	3
Overall Study Withdrawal by Subject	1	6
Overall Study Ineligible	4	5
Overall Study Entry onto another COG study	0	1
Overall Study Refusal by patient/parent/guardian	8	59

Baseline Characteristics

Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

Baseline characteristics by cohort

Measure	Regimen A n=116 Participants Randomized to Regimen A - RA Only	Regimen B n=1333 Participants Regimen B - RA + Immunotherapy	Total n=1449 Participants Total of all reporting groups
Age, Categorical <=18 years	116 Participants n=45 Participants	1325 Participants n=12929 Participants	1441 Participants n=6349 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=45 Participants	8 Participants n=12929 Participants	8 Participants n=6349 Participants
Age, Categorical >=65 years	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Age, Continuous	3.22 Years STANDARD_DEVIATION 2.12 • n=45 Participants	3.64 Years STANDARD_DEVIATION 2.77 • n=12929 Participants	3.61 Years STANDARD_DEVIATION 2.73 • n=6349 Participants
Sex: Female, Male Female	49 Participants n=45 Participants	534 Participants n=12929 Participants	583 Participants n=6349 Participants
Sex: Female, Male Male	67 Participants n=45 Participants	799 Participants n=12929 Participants	866 Participants n=6349 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=45 Participants	142 Participants n=12929 Participants	153 Participants n=6349 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=45 Participants	1159 Participants n=12929 Participants	1258 Participants n=6349 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=45 Participants	32 Participants n=12929 Participants	38 Participants n=6349 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants	3 Participants n=12929 Participants	3 Participants n=6349 Participants
Race (NIH/OMB) Asian	4 Participants n=45 Participants	62 Participants n=12929 Participants	66 Participants n=6349 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=45 Participants	2 Participants n=12929 Participants	4 Participants n=6349 Participants
Race (NIH/OMB) Black or African American	8 Participants n=45 Participants	153 Participants n=12929 Participants	161 Participants n=6349 Participants
Race (NIH/OMB) White	89 Participants n=45 Participants	942 Participants n=12929 Participants	1031 Participants n=6349 Participants
Race (NIH/OMB) More than one race	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=45 Participants	171 Participants n=12929 Participants	184 Participants n=6349 Participants
Region of Enrollment New Zealand	0 participants n=45 Participants	17 participants n=12929 Participants	17 participants n=6349 Participants
Region of Enrollment Canada	13 participants n=45 Participants	135 participants n=12929 Participants	148 participants n=6349 Participants
Region of Enrollment United States	100 participants n=45 Participants	1092 participants n=12929 Participants	1192 participants n=6349 Participants
Region of Enrollment Australia	3 participants n=45 Participants	89 participants n=12929 Participants	92 participants n=6349 Participants

PRIMARY outcome

Timeframe: Three years

Population: Eligible, randomized patients.

Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only

Outcome measures

Measure	Regimen A n=112 Participants Randomized to Regimen A - RA Only	Regimen B n=114 Participants Randomized to Regimen B - RA + Immunotherapy
Event-Free Survival (EFS)	48.1 Percentage of participants Interval 38.4 to 57.8	62.9 Percentage of participants Interval 54.0 to 71.9

SECONDARY outcome

Timeframe: Three years

Population: Eligible, randomized patients with INSS Stage 4 disease. Eligible patients with persistent disease.

Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only for the subgroup of randomized patients with INSS Stage 4 disease. Descriptive comparison of outcome data for patients with persistent disease documented by biopsy to historical data for the analogous patients from CCG-3981.

Outcome measures

Measure	Regimen A n=93 Participants Randomized to Regimen A - RA Only	Regimen B n=127 Participants Randomized to Regimen B - RA + Immunotherapy
Event-Free Survival (EFS) Randomized patients with INSS Stage 4 disease	43.2 Percentage of participants Interval 32.5 to 53.8	59.7 Percentage of participants Interval 49.5 to 69.9
Event-Free Survival (EFS) Eligible patients with persistent disease	—	35.1 Percentage of participants Interval 19.8 to 50.5

SECONDARY outcome

Timeframe: Three years

Population: Eligible patients non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease.

EFS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.

Outcome measures

Measure	Regimen A n=1177 Participants Randomized to Regimen A - RA Only	Regimen B Randomized to Regimen B - RA + Immunotherapy
Event-Free Survival (EFS) of Patients From the Non-randomized Portion of the Trial	64.0 Percentage of participants Interval 60.2 to 67.8	—

SECONDARY outcome

Timeframe: From enrollment to follow-up

Population: Eligible patients enrolled prior to halting of randomization.

Proportion of patients experiencing at least one Grade 3 or higher toxicity.

Outcome measures

Measure	Regimen A n=112 Participants Randomized to Regimen A - RA Only	Regimen B n=141 Participants Randomized to Regimen B - RA + Immunotherapy
Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0	0.64 Proportion Interval 0.55 to 0.73	0.94 Proportion Interval 0.9 to 0.98

SECONDARY outcome

Timeframe: Courses 1-6

Population: Eligible patients assigned to Regimen B, excluding patients with persistent disease.

Number of courses of therapy delivered for patients randomized to RA + Immunotherapy vs. patients non-randomly assigned to RA + Immunotherapy, excluding patients with persistent disease.

Outcome measures

Measure	Regimen A n=1291 Participants Randomized to Regimen A - RA Only	Regimen B Randomized to Regimen B - RA + Immunotherapy
Number of Courses of Therapy Delivered Randomized to Regimen B - RA + Immunotherapy	6 courses per patient Interval 0.0 to 6.0	—
Number of Courses of Therapy Delivered Non-randomly assigned after halting randomization	6 courses per patient Interval 0.0 to 6.0	—

SECONDARY outcome

Timeframe: Three years

Population: Eligible, randomized patients. Eligible, randomized patients with INSS Stage 4 disease.

Comparison to determine if RA + Immunotherapy improves OS as compared to RA Only. Comparison to determine if RA + Immunotherapy improves OS as compared to RA only and for the subgroup of randomized patients with INSS Stage 4 disease.

Outcome measures

Measure	Regimen A n=112 Participants Randomized to Regimen A - RA Only	Regimen B n=114 Participants Randomized to Regimen B - RA + Immunotherapy
Overall Survival (OS) Randomized patients with INSS Stage 4 disease	64.0 Percentage of participants Interval 53.8 to 74.3	78.7 Percentage of participants Interval 70.2 to 87.2
Overall Survival (OS) Randomized patients	67.4 Percentage of participants Interval 58.3 to 76.5	78.8 Percentage of participants Interval 71.2 to 86.4

SECONDARY outcome

Timeframe: Three years

Population: Eligible patients non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease

OS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.

Outcome measures

Measure	Regimen A n=1177 Participants Randomized to Regimen A - RA Only	Regimen B Randomized to Regimen B - RA + Immunotherapy
Overall Survival (OS) of Patients From the Non-randomized Portion of the Trial	78.4 Percentage of participants Interval 75.1 to 81.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 10 years

The average level of HACA at each collection time point during immunotherapy will be calculated.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 10 years

In general, descriptive summaries will include n, mean, standard deviation, median, minimum, maximum and 90% confidence intervals for continuous variables, and n and percent for categorical variables. Summaries will present data by assessment time when appropriate.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 10 years

A descriptive analysis of the change from baseline of MRD will be performed. Also, a Wilcoxon rank-sum test will be performed to compare the median change from baseline of MRD between the two treatment arms. A multivariate Cox proportional hazards regression model will test to see if the change in MRD burden is associated with EFS or OS.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to up to 10 years

A multivariate Cox proportional hazards regression model will test to see if the dinutuximab serum level, HACA titer, effector cell function, or serum marker for effector cell activation are associated with EFS or OS.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week before first sargramostim injection (day -1 of course 1)

Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of circulating B7-H6 level, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of circulating B7-H6 level, adjusting for significant prognostic factors including MYCN status, INSS stage, histology and age at diagnosis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 10 years

Kaplan-Meier plots of EFS will be generated for the three genotype subgroups of FcR as well as for the three genotype subgroups of Kir/Kir-ligand. In addition, a log rank test comparison will be made in a pairwise fashion of each of the genotypes within FcR and within Kir/Kir-ligand.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 10 years

Kaplan-Meier plots of EFS will be generated for the three genotype subgroups of FcR as well as for the three genotype subgroups of Kir/Kir-ligand. In addition, a log rank test comparison will be made in a pairwise fashion of each of the genotypes within FcR and within Kir/Kir-ligand.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 4 hours after administration on day 14 of course 1

To determine if there is a relationship of the peak serum concentration level with EFS, the term for this level will be tested in a Cox proportional hazards model. To determine if there is a relationship of the peak serum concentration level with toxicity rates, Kendall's Tau statistic will be calculated.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 10 years

Will be descriptively compared.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week before first sargramostim injection (day -1 of course 1)

Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of NKp30 isoform expression and SNP, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of NKp30 isoform expression and SNP, adjusting for significant prognostic factors including v-MYC myelocytomatosis viral related oncogene, neuroblastoma derived (avian) (MYCN) status, INSS stage, histology and age at diagnosis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 10 years

A Fisher's exact test will be performed to determine if the presence of naturally occurring anti-glycan antibodies correlates with allergic reactions. A Wilcoxon test will be performed to determine if the presence of naturally occurring anti-glycan antibodies correlates with blood levels of dinutuximab.

Outcome measures

Outcome data not reported

Adverse Events

Regimen A

Serious events: 10 serious events

Other events: 92 other events

Deaths: 0 deaths

Regimen B

Serious events: 785 serious events

Other events: 1244 other events

Deaths: 0 deaths

Serious adverse events

Measure	Regimen A n=112 participants at risk Randomized to Regimen A - RA Only	Regimen B n=1328 participants at risk Regimen B - RA + Immunotherapy
Gastrointestinal disorders Esophageal stenosis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Esophageal ulcer	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Esophagitis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Gastritis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Gastrointestinal disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Gastrointestinal fistula	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Ileal obstruction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Ileus	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.75% 10/1328 • Number of events 10 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Jejunal obstruction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Malabsorption	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Nausea	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Proctitis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Small intestinal obstruction	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Typhlitis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Vomiting	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.1% 14/1328 • Number of events 16 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Chills	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Death NOS	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Edema face	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.90% 12/1328 • Number of events 13 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Edema limbs	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Edema trunk	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Fatigue	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.60% 8/1328 • Number of events 8 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Fever	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	9.1% 121/1328 • Number of events 148 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Flu like symptoms	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Gait disturbance	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders General disorders and administration site conditions - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Infusion related reaction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Injection site reaction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Irritability	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Localized edema	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Non-cardiac chest pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	3.5% 47/1328 • Number of events 68 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Hepatobiliary disorders Hepatic failure	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Hepatobiliary disorders Hepatobiliary disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Immune system disorders Allergic reaction	0.89% 1/112 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	10.6% 141/1328 • Number of events 185 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Immune system disorders Anaphylaxis	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	11.5% 153/1328 • Number of events 180 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Immune system disorders Cytokine release syndrome	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.7% 23/1328 • Number of events 35 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Immune system disorders Immune system disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Immune system disorders Serum sickness	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Abdominal infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Anorectal infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Bladder infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Bone infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Bronchial infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Catheter related infection	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	6.6% 88/1328 • Number of events 105 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Device related infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Enterocolitis infectious	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.83% 11/1328 • Number of events 11 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Eye infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Infections and infestations - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	8.5% 113/1328 • Number of events 145 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Kidney infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Lung infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.98% 13/1328 • Number of events 14 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Mucosal infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Otitis externa	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Peripheral nerve infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Sepsis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.5% 33/1328 • Number of events 35 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Skin infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Upper respiratory infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.68% 9/1328 • Number of events 10 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Urinary tract infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.83% 11/1328 • Number of events 13 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Wound infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Injury, poisoning and procedural complications Fracture	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Alanine aminotransferase increased	1.8% 2/112 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.7% 36/1328 • Number of events 45 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Alkaline phosphatase increased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Aspartate aminotransferase increased	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.1% 28/1328 • Number of events 30 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Blood bilirubin increased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.6% 21/1328 • Number of events 21 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Cardiac troponin I increased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Creatinine increased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.1% 14/1328 • Number of events 15 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Fibrinogen decreased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations GGT increased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.1% 14/1328 • Number of events 18 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations INR increased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Investigations - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Lipase increased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Lymphocyte count decreased	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.3% 17/1328 • Number of events 22 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Neutrophil count decreased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.3% 30/1328 • Number of events 31 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Platelet count decreased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.2% 29/1328 • Number of events 44 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Serum amylase increased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Urine output decreased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.0% 27/1328 • Number of events 37 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Weight gain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.60% 8/1328 • Number of events 8 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Weight loss	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations White blood cell decreased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.1% 15/1328 • Number of events 17 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Acidosis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.75% 10/1328 • Number of events 10 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Anorexia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.2% 16/1328 • Number of events 18 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Dehydration	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.7% 22/1328 • Number of events 22 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.8% 24/1328 • Number of events 35 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.75% 10/1328 • Number of events 10 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypertriglyceridemia	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.7% 23/1328 • Number of events 25 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.7% 23/1328 • Number of events 25 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	4.9% 65/1328 • Number of events 71 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	5.0% 66/1328 • Number of events 76 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.9% 38/1328 • Number of events 40 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 8 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.68% 9/1328 • Number of events 12 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.5% 20/1328 • Number of events 29 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Depressed level of consciousness	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.53% 7/1328 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Dysphasia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Encephalopathy	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Extrapyramidal disorder	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Headache	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.83% 11/1328 • Number of events 12 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Hydrocephalus	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Intracranial hemorrhage	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Myelitis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Nervous system disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Neuralgia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.83% 11/1328 • Number of events 12 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Oculomotor nerve disorder	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Reversible posterior leukoencephalopathy syndrome	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Seizure	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.75% 10/1328 • Number of events 10 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Somnolence	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Syncope	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Tremor	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Agitation	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Anxiety	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Confusion	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Delirium	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Depression	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Euphoria	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Insomnia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Personality change	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Psychosis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Suicidal ideation	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Suicide attempt	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Acute kidney injury	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.90% 12/1328 • Number of events 12 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Chronic kidney disease	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Proteinuria	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.68% 9/1328 • Number of events 12 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Renal and urinary disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Urinary frequency	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Urinary retention	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.75% 10/1328 • Number of events 11 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Reproductive system and breast disorders Scrotal pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.83% 11/1328 • Number of events 12 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.3% 30/1328 • Number of events 34 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.2% 16/1328 • Number of events 18 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	4.0% 53/1328 • Number of events 60 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	5.2% 69/1328 • Number of events 85 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.60% 8/1328 • Number of events 8 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Pleural hemorrhage	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.75% 10/1328 • Number of events 10 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Respiratory thoracic and mediastinal disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.53% 7/1328 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Erythema multiforme	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Periorbital edema	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.75% 10/1328 • Number of events 10 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	7.7% 102/1328 • Number of events 128 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Surgical and medical procedures Surgical and medical procedures - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Vascular disorders Capillary leak syndrome	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	11.6% 154/1328 • Number of events 189 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Vascular disorders Hypertension	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.7% 22/1328 • Number of events 24 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Vascular disorders Hypotension	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	18.8% 249/1328 • Number of events 335 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Vascular disorders Thromboembolic event	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Vascular disorders Vascular disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Blood and lymphatic system disorders Anemia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	3.2% 42/1328 • Number of events 49 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Blood and lymphatic system disorders Hemolysis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Blood and lymphatic system disorders Hemolytic uremic syndrome	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Atrial fibrillation	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Cardiac arrest	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Cardiac disorders - Other specify	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Heart failure	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Left ventricular systolic dysfunction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.53% 7/1328 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Pericardial effusion	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Right ventricular dysfunction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Sinus bradycardia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Sinus tachycardia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.98% 13/1328 • Number of events 16 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Supraventricular tachycardia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Ventricular arrhythmia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Ear and labyrinth disorders Ear and labyrinth disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Ear and labyrinth disorders Ear pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Ear and labyrinth disorders Hearing impaired	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Endocrine disorders Adrenal insufficiency	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Endocrine disorders Endocrine disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Endocrine disorders Hypothyroidism	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Blurred vision	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.53% 7/1328 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Eye disorders - Other specify	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.2% 16/1328 • Number of events 16 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Optic nerve disorder	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Papilledema	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Photophobia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Abdominal distension	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.53% 7/1328 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Abdominal pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	3.1% 41/1328 • Number of events 60 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Ascites	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Colitis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.68% 9/1328 • Number of events 10 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Colonic obstruction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Diarrhea	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.6% 35/1328 • Number of events 36 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Esophageal hemorrhage	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Esophageal perforation	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.

Other adverse events

Measure	Regimen A n=112 participants at risk Randomized to Regimen A - RA Only	Regimen B n=1328 participants at risk Regimen B - RA + Immunotherapy
Blood and lymphatic system disorders Anemia	19.6% 22/112 • Number of events 47 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	32.2% 428/1328 • Number of events 962 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other specify	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.2% 16/1328 • Number of events 24 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.4% 19/1328 • Number of events 23 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Blood and lymphatic system disorders Hemolytic uremic syndrome	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Atrial fibrillation	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Cardiac disorders - Other specify	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.7% 36/1328 • Number of events 49 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Chest pain - cardiac	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Conduction disorder	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Heart failure	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Left ventricular systolic dysfunction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Mobitz type I	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Paroxysmal atrial tachycardia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Pericardial effusion	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Sinus bradycardia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Sinus tachycardia	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	3.7% 49/1328 • Number of events 82 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Supraventricular tachycardia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.60% 8/1328 • Number of events 13 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Ventricular arrhythmia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Cardiac disorders Ventricular tachycardia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Ear and labyrinth disorders Ear and labyrinth disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Ear and labyrinth disorders Ear pain	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Ear and labyrinth disorders External ear inflammation	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.00% 0/1328 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Ear and labyrinth disorders Hearing impaired	5.4% 6/112 • Number of events 8 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.7% 22/1328 • Number of events 28 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Ear and labyrinth disorders Middle ear inflammation	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Ear and labyrinth disorders Tinnitus	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Endocrine disorders Adrenal insufficiency	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Endocrine disorders Endocrine disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Endocrine disorders Hyperthyroidism	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Endocrine disorders Hypothyroidism	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Blurred vision	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.90% 12/1328 • Number of events 14 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Conjunctivitis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Dry eye	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Extraocular muscle paresis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Eye disorders - Other specify	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.5% 20/1328 • Number of events 24 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Eye pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Flashing lights	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Photophobia	1.8% 2/112 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.60% 8/1328 • Number of events 8 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Eye disorders Watering eyes	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Abdominal distension	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.68% 9/1328 • Number of events 9 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Abdominal pain	9.8% 11/112 • Number of events 14 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	23.5% 312/1328 • Number of events 566 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Anal mucositis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Anal pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Cheilitis	3.6% 4/112 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.2% 16/1328 • Number of events 29 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Colitis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.83% 11/1328 • Number of events 14 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Colonic stenosis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Constipation	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.8% 24/1328 • Number of events 35 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Diarrhea	14.3% 16/112 • Number of events 26 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	14.8% 196/1328 • Number of events 311 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Dry mouth	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Dysphagia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Esophageal stenosis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Esophagitis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Flatulence	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Gastric ulcer	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Gastritis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Gastrointestinal disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Gastroparesis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Gingival pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Ileus	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Malabsorption	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Mucositis oral	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Nausea	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	3.0% 40/1328 • Number of events 65 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Oral pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.60% 8/1328 • Number of events 9 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Pancreatitis	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.00% 0/1328 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Rectal pain	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Stomach pain	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.2% 16/1328 • Number of events 23 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Toothache	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Gastrointestinal disorders Vomiting	18.8% 21/112 • Number of events 35 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	8.2% 109/1328 • Number of events 196 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Chills	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.3% 31/1328 • Number of events 43 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Edema face	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	3.7% 49/1328 • Number of events 82 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Edema limbs	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.5% 20/1328 • Number of events 28 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Edema trunk	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Facial pain	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Fatigue	1.8% 2/112 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.5% 33/1328 • Number of events 39 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Fever	29.5% 33/112 • Number of events 43 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	40.4% 536/1328 • Number of events 991 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Flu like symptoms	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Gait disturbance	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders General disorders and administration site conditions - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 8 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Hypothermia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Infusion site extravasation	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Injection site reaction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.75% 10/1328 • Number of events 13 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Irritability	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.98% 13/1328 • Number of events 17 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Localized edema	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Non-cardiac chest pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.75% 10/1328 • Number of events 12 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
General disorders Pain	5.4% 6/112 • Number of events 14 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	33.2% 441/1328 • Number of events 941 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Hepatobiliary disorders Cholecystitis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Hepatobiliary disorders Hepatobiliary disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Immune system disorders Allergic reaction	9.8% 11/112 • Number of events 29 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	49.3% 655/1328 • Number of events 1405 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Immune system disorders Anaphylaxis	0.89% 1/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	5.3% 71/1328 • Number of events 92 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Immune system disorders Cytokine release syndrome	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	8.7% 115/1328 • Number of events 205 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Immune system disorders Immune system disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Immune system disorders Serum sickness	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.00% 0/1328 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Abdominal infection	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.60% 8/1328 • Number of events 11 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Anorectal infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Bladder infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Bone infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Bronchial infection	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Catheter related infection	7.1% 8/112 • Number of events 9 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	7.3% 97/1328 • Number of events 128 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Cecal infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Conjunctivitis infective	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Device related infection	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.53% 7/1328 • Number of events 8 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Endocarditis infective	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Enterocolitis infectious	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.9% 39/1328 • Number of events 47 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Esophageal infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Eye infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Gum infection	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Infections and infestations - Other specify	25.9% 29/112 • Number of events 42 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	11.1% 147/1328 • Number of events 255 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Joint infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Lung infection	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.98% 13/1328 • Number of events 13 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Lymph gland infection	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Nail infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Otitis externa	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Otitis media	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Ovarian infection	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.00% 0/1328 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Pelvic infection	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.00% 0/1328 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Peripheral nerve infection	0.89% 1/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Pharyngitis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Pleural infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Rash pustular	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Rhinitis infective	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Salivary gland infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Sepsis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Sinusitis	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Skin infection	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.68% 9/1328 • Number of events 9 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Small intestine infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Tooth infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Upper respiratory infection	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.6% 21/1328 • Number of events 23 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Urinary tract infection	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.0% 27/1328 • Number of events 35 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Infections and infestations Wound infection	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Injury, poisoning and procedural complications Bruising	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Injury, poisoning and procedural complications Burn	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Injury, poisoning and procedural complications Fracture	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Lipase increased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Lymphocyte count decreased	35.7% 40/112 • Number of events 97 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	24.3% 323/1328 • Number of events 739 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Lymphocyte count increased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Neutrophil count decreased	16.1% 18/112 • Number of events 24 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	20.5% 272/1328 • Number of events 470 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Pancreatic enzymes decreased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Platelet count decreased	42.0% 47/112 • Number of events 144 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	26.8% 356/1328 • Number of events 876 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Serum amylase increased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 12 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Urine output decreased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.3% 31/1328 • Number of events 57 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Weight gain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	3.8% 50/1328 • Number of events 90 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Weight loss	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.1% 15/1328 • Number of events 15 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations White blood cell decreased	14.3% 16/112 • Number of events 37 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	11.9% 158/1328 • Number of events 297 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Acidosis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.9% 25/1328 • Number of events 48 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Alkalosis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Anorexia	4.5% 5/112 • Number of events 12 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	7.5% 100/1328 • Number of events 189 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Dehydration	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.1% 14/1328 • Number of events 14 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypercalcemia	7.1% 8/112 • Number of events 17 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.7% 36/1328 • Number of events 44 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hyperglycemia	3.6% 4/112 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	5.8% 77/1328 • Number of events 129 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hyperkalemia	3.6% 4/112 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	3.5% 46/1328 • Number of events 58 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypermagnesemia	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.98% 13/1328 • Number of events 13 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypernatremia	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.90% 12/1328 • Number of events 12 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypertriglyceridemia	9.8% 11/112 • Number of events 17 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	5.8% 77/1328 • Number of events 162 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypoalbuminemia	2.7% 3/112 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	11.7% 156/1328 • Number of events 359 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypocalcemia	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	9.6% 128/1328 • Number of events 229 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.2% 29/1328 • Number of events 35 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypokalemia	5.4% 6/112 • Number of events 12 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	30.8% 409/1328 • Number of events 664 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypomagnesemia	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	3.0% 40/1328 • Number of events 55 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hyponatremia	11.6% 13/112 • Number of events 31 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	19.7% 262/1328 • Number of events 466 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Hypophosphatemia	2.7% 3/112 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	8.6% 114/1328 • Number of events 141 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Metabolism and nutrition disorders Iron overload	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Arthralgia	2.7% 3/112 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.1% 14/1328 • Number of events 18 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Back pain	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	5.2% 69/1328 • Number of events 97 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Bone pain	1.8% 2/112 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.1% 14/1328 • Number of events 17 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Chest wall pain	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.2% 16/1328 • Number of events 19 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Movements involuntary	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Nervous system disorders - Other specify	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Neuralgia	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	4.0% 53/1328 • Number of events 119 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Oculomotor nerve disorder	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Peripheral motor neuropathy	3.6% 4/112 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.90% 12/1328 • Number of events 17 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Peripheral sensory neuropathy	0.89% 1/112 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.4% 19/1328 • Number of events 27 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Seizure	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.68% 9/1328 • Number of events 9 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Somnolence	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Stroke	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Syncope	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Vasovagal reaction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Agitation	1.8% 2/112 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.1% 15/1328 • Number of events 20 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Anxiety	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Confusion	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Depression	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Euphoria	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Hallucinations	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Personality change	3.6% 4/112 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Psychiatric disorders Psychosis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Acute kidney injury	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Bladder spasm	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Chronic kidney disease	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Hematuria	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.3% 17/1328 • Number of events 22 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Hemoglobinuria	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Proteinuria	2.7% 3/112 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.4% 32/1328 • Number of events 42 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Renal and urinary disorders - Other specify	0.89% 1/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.75% 10/1328 • Number of events 13 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Renal hemorrhage	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.00% 0/1328 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Urinary frequency	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.00% 0/1328 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Urinary retention	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.3% 30/1328 • Number of events 47 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Urinary tract pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Renal and urinary disorders Urine discoloration	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Reproductive system and breast disorders Pelvic pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Reproductive system and breast disorders Penile pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.75% 10/1328 • Number of events 12 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Reproductive system and breast disorders Perineal pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Reproductive system and breast disorders Vaginal pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.89% 1/112 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.89% 1/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.2% 29/1328 • Number of events 36 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Cough	1.8% 2/112 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	6.3% 84/1328 • Number of events 115 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.7% 3/112 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	8.4% 111/1328 • Number of events 146 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.7% 3/112 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.7% 3/112 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	13.5% 179/1328 • Number of events 275 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.90% 12/1328 • Number of events 16 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Respiratory thoracic and mediastinal disorders - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.75% 10/1328 • Number of events 10 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.00% 0/1328 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.53% 7/1328 • Number of events 10 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.30% 4/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Dry skin	14.3% 16/112 • Number of events 29 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	4.3% 57/1328 • Number of events 98 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Erythema multiforme	5.4% 6/112 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Nail loss	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.00% 0/1328 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.98% 13/1328 • Number of events 15 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Periorbital edema	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Pruritus	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	4.5% 60/1328 • Number of events 89 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.5% 5/112 • Number of events 8 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	3.1% 41/1328 • Number of events 48 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other specify	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.7% 22/1328 • Number of events 35 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Skin and subcutaneous tissue disorders Urticaria	5.4% 6/112 • Number of events 9 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	45.6% 606/1328 • Number of events 1151 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Vascular disorders Capillary leak syndrome	1.8% 2/112 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	40.1% 533/1328 • Number of events 1089 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Vascular disorders Flushing	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.38% 5/1328 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Vascular disorders Hematoma	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Vascular disorders Hypertension	6.2% 7/112 • Number of events 16 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	3.6% 48/1328 • Number of events 67 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Vascular disorders Hypotension	5.4% 6/112 • Number of events 9 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	60.0% 797/1328 • Number of events 1824 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Vascular disorders Thromboembolic event	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Vascular disorders Vascular disorders - Other specify	2.7% 3/112 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.3% 17/1328 • Number of events 24 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Injury, poisoning and procedural complications Injury poisoning and procedural complications - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.23% 3/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Activated partial thromboplastin time prolonged	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.45% 6/1328 • Number of events 6 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Alanine aminotransferase increased	29.5% 33/112 • Number of events 79 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	21.2% 281/1328 • Number of events 560 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Alkaline phosphatase increased	6.2% 7/112 • Number of events 14 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.6% 35/1328 • Number of events 53 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Aspartate aminotransferase increased	5.4% 6/112 • Number of events 11 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	13.6% 180/1328 • Number of events 279 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Blood bilirubin increased	4.5% 5/112 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.1% 28/1328 • Number of events 40 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations CD4 lymphocytes decreased	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Cholesterol high	0.89% 1/112 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.90% 12/1328 • Number of events 30 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Creatinine increased	5.4% 6/112 • Number of events 12 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	3.3% 44/1328 • Number of events 67 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Fibrinogen decreased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Forced expiratory volume decreased	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.00% 0/1328 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations GGT increased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	7.3% 97/1328 • Number of events 217 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations INR increased	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Investigations Investigations - Other specify	1.8% 2/112 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	1.4% 18/1328 • Number of events 28 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other specify	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Myalgia	1.8% 2/112 • Number of events 4 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.68% 9/1328 • Number of events 11 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	2.0% 26/1328 • Number of events 36 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Pain in extremity	3.6% 4/112 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	9.9% 132/1328 • Number of events 207 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Musculoskeletal and connective tissue disorders Pelvic soft tissue necrosis	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Ataxia	0.89% 1/112 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Depressed level of consciousness	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.53% 7/1328 • Number of events 7 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Dizziness	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 2 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Dysgeusia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.15% 2/1328 • Number of events 3 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Dysphasia	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Headache	3.6% 4/112 • Number of events 5 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	4.2% 56/1328 • Number of events 73 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Hypoglossal nerve disorder	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Intracranial hemorrhage	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.
Nervous system disorders Memory impairment	0.00% 0/112 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.	0.08% 1/1328 • Number of events 1 Ineligible patients were excluded from the adverse event analysis, so only eligible patients are reported.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: resultsreportingcoordinator@childrensoncologygroup.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60