Trial Outcomes & Findings for Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myeloma (NCT NCT00112827)

NCT ID: NCT00112827

Last Updated: 2025-06-06

Results Overview

The highest dose tested (Total Marrow Irradiation) in which there is no treatment related mortality and none or only one patient experienced dose limited toxicity (DLT) attributable to the study drug(s), when at least six were fully treated at that dose and fully followed for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the treatment or there was a treatment related death. At least 6 patients will be treated at the MTD.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 54 participants
• Primary outcome timeframe: 8 weeks from start of treatment, up to 2 years
• Results posted on: 2025-06-06

Participant Flow

Participant milestones

Measure	Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy) See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy) See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy) See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy) See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy) See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
Overall Study STARTED	3	4	4	36	7
Overall Study COMPLETED	3	4	4	36	7
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myeloma

Baseline characteristics by cohort

Measure	Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy) n=3 Participants See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy) n=4 Participants See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy) n=4 Participants See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy) n=36 Participants See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy) n=7 Participants See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Total n=54 Participants Total of all reporting groups
Age, Continuous	49 years n=5 Participants	56 years n=7 Participants	54 years n=5 Participants	54 years n=4 Participants	54 years n=21 Participants	54 years n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants	4 Participants n=21 Participants	23 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	23 Participants n=4 Participants	3 Participants n=21 Participants	31 Participants n=8 Participants
Race/Ethnicity, Customized African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=8 Participants
Race/Ethnicity, Customized Caucasian	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	22 Participants n=4 Participants	4 Participants n=21 Participants	35 Participants n=8 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	7 Participants n=8 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	36 participants n=4 Participants	7 participants n=21 Participants	54 participants n=8 Participants

PRIMARY outcome

Timeframe: 8 weeks from start of treatment, up to 2 years

Population: All patients enrolled in the dose-finding portion of the study.

The highest dose tested (Total Marrow Irradiation) in which there is no treatment related mortality and none or only one patient experienced dose limited toxicity (DLT) attributable to the study drug(s), when at least six were fully treated at that dose and fully followed for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the treatment or there was a treatment related death. At least 6 patients will be treated at the MTD.

Outcome measures

Measure	Treatment Arm n=24 Participants See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy) See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy) See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy) See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy) See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
Maximum Tolerated Dose (MTD)	1600 cGy	—	—	—	—

PRIMARY outcome

Timeframe: Evaluated after each course until completion of treatment.

Response defined as complete response or very good partial response. Complete response defined as the absence of bone marrow or blood findings of multiple myeloma on at least 2 measurements at a minimum of a 6 week interval. Thus all evidence of serum and urinary M-components must disappear on electrophoresis as well as by immunofixation studies. The follow-up bone marrow may not contain more than 5% plasma cells on aspiration or core biopsy and no evidence of increasing anemia. Skeletal X-rays must either show recalcification or no change in osteolytic lesions. Resolution of soft tissue plasmocytomas. Very good partial response defined as reduction of bone marrow or blood findings of multiple myeloma on at least 2 measurements at a minimum of a 6 week interval by greater than or equal to 90%.

Outcome measures

Measure	Treatment Arm n=3 Participants See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy) n=4 Participants See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy) n=4 Participants See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy) n=36 Participants See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy) n=7 Participants See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
Number of Subjects With Response	3 Participants	3 Participants	2 Participants	20 Participants	4 Participants

PRIMARY outcome

Timeframe: From date of treatment until the date of death from any cause, assessed up to 14 years

Population: Overall survival was calculated for aggregated arms, due to small number of patients in most treatment arms.

Estimated using the product-limit method of Kaplan and Meier. Event defined as death due to any cause.

Outcome measures

Measure	Treatment Arm n=54 Participants See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy) See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy) See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy) See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy) See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
Overall Survival	95.8 months Interval 52.4 to Upper 95% confidence interval was not reached.	—	—	—	—

Adverse Events

Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 3 deaths

Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 4 deaths

Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy)

Serious events: 6 serious events

Other events: 33 other events

Deaths: 20 deaths

Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy)

Serious events: 3 serious events

Other events: 7 other events

Deaths: 4 deaths

Serious adverse events

Measure	Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy) n=3 participants at risk See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy) n=4 participants at risk See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy) n=4 participants at risk See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy) n=36 participants at risk See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy) n=7 participants at risk See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sepsis	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Syncope	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Renal failure	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash desquamating	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Measure	Phase 1 Cohort 1 (Total TMI Dose: 1000 cGy) n=3 participants at risk See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 2 (Total TMI Dose: 1200 cGy) n=4 participants at risk See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 3 (Total TMI Dose: 1400 cGy) n=4 participants at risk See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 4 & Phase 2 MTD (Total TMI Dose:1600 cGy) n=36 participants at risk See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally	Phase 1 Cohort 5 (Total TMI Dose: 1800 cGy) n=7 participants at risk See Detailed Description total marrow irradiation: Undergo irradiation escalating according to the following schedule 1000cGy, 1200cGy, 1400cGy, 1600cGy, 1800cGy melphalan: Given IV peripheral blood stem cell transplantation: Undergo transplantation filgrastim: Given IV fluorescence in situ hybridization: Correlative studies cytogenetic analysis: Correlative studies cyclophosphamide: Given IV autologous-autologous tandem hematopoietic stem cell transplantation: Undergo transplantation lenalidomide: Given orally
Nervous system disorders Oculomotor nerve disorder	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	66.7% 2/3 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	58.3% 21/36 • Number of events 35 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Sinus pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Speech disorder	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Syncope	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Taste alteration	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 4/36 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Tremor	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Agitation	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	66.7% 2/3 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.8% 10/36 • Number of events 11 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	100.0% 3/3 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.6% 11/36 • Number of events 16 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Bladder pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Cystitis	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Hemorrhage urinary tract	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Febrile neutropenia	33.3% 1/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.6% 11/36 • Number of events 11 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Hemoglobin decreased	100.0% 3/3 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 4/4 • Number of events 10 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	88.9% 32/36 • Number of events 85 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 7/7 • Number of events 28 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Lymphatic disorder	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Arrhythmia	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Cardiac disorder	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Conduction disorder	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Left ventricular failure	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Mobitz type I	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Palpitations	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.9% 5/36 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Pericardial effusion	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Pericarditis	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus bradycardia	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Wolff-Parkinson-White syndrome	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders External ear pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Dry eye syndrome	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Flashing vision	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Vision blurred	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.9% 5/36 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	66.7% 2/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.8% 10/36 • Number of events 12 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	71.4% 5/7 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Anal hemorrhage	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Anal pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 18/36 • Number of events 26 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	71.4% 5/7 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	66.7% 2/3 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 4/4 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 30/36 • Number of events 39 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	85.7% 6/7 • Number of events 12 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 6/36 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	33.3% 12/36 • Number of events 15 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Ear, nose and throat examination abnormal	66.7% 2/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.6% 11/36 • Number of events 14 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophageal mucositis	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophageal pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophagitis	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Flatulence	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastric mucositis	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastritis	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gingival pain	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Hemorrhoids	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	19.4% 7/36 • Number of events 9 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	100.0% 3/3 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 4/4 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	80.6% 29/36 • Number of events 50 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 7/7 • Number of events 15 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oesophagoscopy abnormal	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 6/36 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Retroperitoneal hemorrhage	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Stomach pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 4/36 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	100.0% 3/3 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	63.9% 23/36 • Number of events 32 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	85.7% 6/7 • Number of events 9 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chest pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	19.4% 7/36 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Disease progression	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 4/36 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	66.7% 2/3 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.8% 10/36 • Number of events 12 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Facial pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	100.0% 3/3 • Number of events 8 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	72.2% 26/36 • Number of events 48 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	85.7% 6/7 • Number of events 10 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 9/36 • Number of events 9 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders General symptom	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 6/36 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Ill-defined disorder	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Injection site reaction	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Localized edema	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	33.3% 1/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	19.4% 7/36 • Number of events 12 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	71.4% 5/7 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Visceral edema	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Immune system disorder	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Abdominal infection	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Anal infection	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Bronchitis	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Catheter related infection	66.7% 2/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Conjunctivitis infective	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Gingival infection	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infectious colitis	33.3% 1/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Lip infection	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Opportunistic infection	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Peripheral nerve infection	33.3% 1/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Pneumonia	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sepsis	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.8% 10/36 • Number of events 10 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper respiratory infection	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Urinary tract infection	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Activated partial thromboplastin time prolonged	33.3% 1/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	66.7% 2/3 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 4/4 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	52.8% 19/36 • Number of events 29 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 7/7 • Number of events 13 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	19.4% 7/36 • Number of events 8 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	100.0% 3/3 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	47.2% 17/36 • Number of events 27 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	85.7% 6/7 • Number of events 11 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Bilirubin increased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood gonadotrophin abnormal	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.9% 5/36 • Number of events 8 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Electrocardiogram QTc interval prolonged	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypercholesterolemia	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Laboratory test abnormal	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukocyte count decreased	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	83.3% 30/36 • Number of events 63 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 11 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	100.0% 3/3 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 4/4 • Number of events 13 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 13 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 37 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	33.3% 1/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	52.8% 19/36 • Number of events 31 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	100.0% 3/3 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 4/4 • Number of events 11 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 9 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 23 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	100.0% 3/3 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 9 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	77.8% 28/36 • Number of events 57 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 7/7 • Number of events 27 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	100.0% 3/3 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 4/4 • Number of events 10 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	88.9% 32/36 • Number of events 70 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 7/7 • Number of events 43 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Serum cholesterol increased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	19.4% 7/36 • Number of events 8 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.2% 8/36 • Number of events 10 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.8% 10/36 • Number of events 13 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Alkalosis	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	33.3% 1/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	58.3% 21/36 • Number of events 32 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 7/7 • Number of events 11 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood bicarbonate decreased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.9% 5/36 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood glucose increased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	61.1% 22/36 • Number of events 31 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood uric acid increased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	66.7% 2/3 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 3/3 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 4/4 • Number of events 10 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 8 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 11 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	100.0% 3/3 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 4/4 • Number of events 8 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 12 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 8 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypomagnesemia	33.3% 1/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	75.0% 3/4 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	66.7% 2/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	100.0% 4/4 • Number of events 8 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 8 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Obesity	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum albumin decreased	33.3% 1/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	80.6% 29/36 • Number of events 53 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 10 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium decreased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	77.8% 28/36 • Number of events 50 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium increased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	19.4% 7/36 • Number of events 8 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum glucose decreased	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.6% 11/36 • Number of events 12 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum magnesium decreased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.6% 11/36 • Number of events 15 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum magnesium increased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum phosphate decreased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	58.3% 21/36 • Number of events 32 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium decreased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 18/36 • Number of events 28 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 8 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium increased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum sodium decreased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	58.3% 21/36 • Number of events 34 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum sodium increased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum triglycerides increased	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Back pain	100.0% 3/3 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 18/36 • Number of events 29 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Bone pain	66.7% 2/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.8% 10/36 • Number of events 13 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint pain	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 4/36 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	19.4% 7/36 • Number of events 9 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	38.9% 14/36 • Number of events 19 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	33.3% 1/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Depressed level of consciousness	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 6/36 • Number of events 8 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	71.4% 5/7 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 18/36 • Number of events 23 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	42.9% 3/7 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Memory impairment	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Neuralgia	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Neurological disorder NOS	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	28.6% 2/7 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Protein urine positive	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.9% 5/36 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Renal failure	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urethral pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary frequency	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary retention	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urogenital disorder	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Gynecomastia	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 6/36 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Perineal pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal hemorrhage	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal inflammation	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	66.7% 2/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.6% 11/36 • Number of events 15 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	57.1% 4/7 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	66.7% 2/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hiccough	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal mucositis	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.1% 4/36 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	8.3% 3/36 • Number of events 3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Erythema multiforme	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.9% 5/36 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash desquamating	66.7% 2/3 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	61.1% 22/36 • Number of events 29 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	85.7% 6/7 • Number of events 9 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin disorder	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 6/36 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.9% 5/36 • Number of events 5 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Sweating	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.6% 2/36 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Flushing	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.9% 5/36 • Number of events 6 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 2 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hemorrhage	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hot flashes	33.3% 1/3 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	25.0% 9/36 • Number of events 12 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	16.7% 6/36 • Number of events 7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Phlebitis	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.8% 1/36 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/7 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thrombosis	0.00% 0/3 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/4 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/36 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	14.3% 1/7 • Number of events 1 • Adverse events occurred over a period of 14 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-218-5265

Email: pfrankel@coh.org

Results disclosure agreements

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